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510(k) Data Aggregation
K Number
K132208Device Name
ONTEX AND OTHERS PROPRIETARY NAMES
Manufacturer
ONTEX BVBA
Date Cleared
2014-04-10
(268 days)
Product Code
HIL, DEV
Regulation Number
884.5460Why did this record match?
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Matched: '884.5460'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Scented Digital and Plastic Applicator Tampons are inserted into the vagina to absorb menstrual discharge.
Device Description
The Scented Tampons are:
1) Scented Digital
2) Scented Plastic Applicator (full size (long) and compact)
They are scented versions because of the presence of a fragrance.
Both the Applicator and Digital Tampons are inserted into the vagina to absorb menstrual discharge.
These tampons, both the digital types and the applicator types will be provided with 4 absorbencies: light (<6g), regular (6-9g), super (9-12g), and super plus (12-15g).
These tampons are made from viscose material and polymeric overwrap. The withdrawal cord is in polyester and cotton. Applicators are in polyethylene.
Roll-tampon: sheet of absorbent material is rolled and pressed. W-tampon: sheet of absorbent material is folded and pressed from two sides simultaneously.
Long applicator: inner tube and outer tube are ready to be used immediately. Compact applicator: inner tube and outer tube are slided into each other telescopically. The inner tube needs to be retracted before usage.
Except for the perfume, the materials used in these tampons are similar to materials of legally marketed tampons.
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K Number
K132819Device Name
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
Manufacturer
PLAYTEX MANUFACTURING INC.
Date Cleared
2013-10-09
(30 days)
Product Code
HIL, HEB
Regulation Number
884.5460Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Playtex scented (or scented deodorized) and unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Absorbency Ranges:
Absorbs menstrual flow < 6 grams (Light)
Absorbs menstrual flow 6-9 grams (Regular)
Absorbs menstrual flow 9-12 grams (Super)
Absorbs menstrual flow 12-15 grams (Super Plus)
Device Description
Scented (or scented deodorized) and unscented menstrual tampons for the absorption of menstrual fluid. The tampon consists of a pledget, string and applicator (barrel and plunger).
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K Number
K120245Device Name
PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
Manufacturer
PLAYTEX, INC.
Date Cleared
2012-06-21
(146 days)
Product Code
HIL, HEB
Regulation Number
884.5460Why did this record match?
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Matched: '884.5460'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Playtex® Gentle Glide Scented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Playtex® Gentle Glide Unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Absorbency Ranges:
Absorbs menstrual flow < 6 grams (Slender Light)
Absorbs menstrual flow 6-9 grams (Slender Regular, Regular)
Absorbs menstrual flow 9-12 grams (Super)
Absorbs menstrual flow 12-15 grams (Super Plus)
Absorbs menstrual flow 15-18 grams (Ultra)
Device Description
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
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K Number
K111684Device Name
PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
Manufacturer
PLAYTEX MANUFACTURING INC.
Date Cleared
2012-02-03
(233 days)
Product Code
HIL
Regulation Number
884.5460Why did this record match?
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Matched: '884.5460'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Playtex scented or scented deodorized menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid; Playtex unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Device Description
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
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K Number
K102445Device Name
ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS
Manufacturer
ROSTAM LTD.
Date Cleared
2010-11-10
(76 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rostan Scented and Unscented Biodegradable Plastic Applicator Tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Device Description
Rostam plastic scented and unscented biodegradable applicator tampons are being submitted to obtain clearance for a new material applicator. They are menstrual tampons used to absorb menstrual fluid. These Tanıpons will be provided with 4 absorbencies, light, regular, super and super plus.
These Tampons are made from rayon and/or cotton (as the absorbent material) polymeric overwrap, cotton/polyester sewing thread and cotton cord.
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K Number
K091281Device Name
TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA
Manufacturer
PROCTER & GAMBLE CO.
Date Cleared
2010-06-01
(396 days)
Product Code
HEB, HFB
Regulation Number
884.5470Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TAMPAX® Pearl Plastic Applicator Unscented Tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Device Description
The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, an overwrap, a withdrawal cord, an absorbent braid, and an applicator.
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K Number
K090071Device Name
ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS
Manufacturer
ROSTAM LTD.
Date Cleared
2009-05-28
(136 days)
Product Code
HEB, HIL
Regulation Number
884.5470Why did this record match?
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Matched: '884.5460'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rostam Fragranced and Unfragranced Compact Applicator Tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge
Device Description
Rostam plastic applicator tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, Light, regular and super. These Tampons are made from rayon and/or cotton polymeric overwrap and cotton cord. The materials used in these tampons are similar to those used in other legally marketed tampons.
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K Number
K081555Device Name
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
Manufacturer
PROCTER & GAMBLE CO.
Date Cleared
2008-06-27
(24 days)
Product Code
HIL
Regulation Number
884.5460Why did this record match?
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Matched: '884.5460'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TAMPAX® Pearl Plastic™ unscented and scented Tampons are intended to be inserted into the vagina to absorb menstrual fluid.
Device Description
Scented or scented deodorized, unscented menstrual tampons for absorption of menstrual fluid.
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K Number
K073662Device Name
PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
Manufacturer
PLAYTEX PRODUCTS, INC.
Date Cleared
2008-01-17
(22 days)
Product Code
HIL
Regulation Number
884.5460Why did this record match?
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Matched: '884.5460'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.
Device Description
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
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K Number
K072376Device Name
PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS
Manufacturer
PLAYTEX PRODUCTS, INC.
Date Cleared
2007-12-12
(110 days)
Product Code
HIL
Regulation Number
884.5460Why did this record match?
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Matched: '884.5460'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.
Device Description
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
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