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Found 9 results
510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
ROSTAM LTD.
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
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?
Applicant Name (Manufacturer) :
ROSTAM LTD.
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
K062001Device Name
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
Manufacturer
ROSTAM LTD.
Date Cleared
2006-12-07
(146 days)
Product Code
HEB, HIL
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
ROSTAM LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rostam Ltd. Fragranced and Unfragranced plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to apsorb menstrual or other vaginal discharge
Device Description
Rostam plastic applicator tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided as two absorbencies, slender regular and light. 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
K042773Device Name
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
Manufacturer
ROSTAM LTD.
Date Cleared
2004-11-23
(49 days)
Product Code
HIL
Regulation Number
884.5460Why did this record match?
Applicant Name (Manufacturer) :
ROSTAM LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As a Class II Device, the menstrual tampon is defined as follows: (21CFR884.5460 and 21CFR 884 5470).
Rostam Ltd. Fragranced plastic applicator tampons are a plug of Cellulosic or synthetic material that is 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, regular, super and super plus.
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
K030474Device Name
PH BUFFERING PLASTIC APPLICATOR TAMPON
Manufacturer
ROSTAM LTD.
Date Cleared
2004-05-28
(471 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
ROSTAM LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rostam pH Tampon is a menstrual tampon for the absorption of menstrual fluid. The pH Tampon reduces the usual vaginal pH increase during menses.
Device Description
The Rostam pH Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed at the first stage in two absorbencies: regular and super. The Tampons reduce the usual vaginal pH increase during menses. These Tampons are made from rayon and cotton cord. The materials used in these tampons are similar to those used in other legally marketed tampons in the US, with the exception of an additive that is designed to reduce the usual increase in vaginal pH during menstruation.
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K Number
K032080Device Name
ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS
Manufacturer
ROSTAM LTD.
Date Cleared
2003-08-14
(38 days)
Product Code
HIL
Regulation Number
884.5460Why did this record match?
Applicant Name (Manufacturer) :
ROSTAM LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rostam Ltd fragranced plastic applicator tampons are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Device Description
Rostam plastic applicators are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 5 absorbencies, junior (MINI), regular, slender regular, super and super plus. These Tampons are made from rayon and cotton and cotton cord. The material used in these tampons are similar to those used in other legally marketed tampons.
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K Number
K020535Device Name
INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
Manufacturer
ROSTAM LTD.
Date Cleared
2002-05-09
(79 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
ROSTAM LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As a Class II device, the menstrual tampon is defined as follows: (21 CFR 884.5460 and 21 CFR 884.5470) Rostam applicator tampons are made of cellulosic or synthetic material that is inserted ire the vagina and used to absorb menstrual or other discharge.
Device Description
Rostam Interlude Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed in three absorbencies: regular, super and super plus. These Tampons are made from rayon and cotton and cotton cord. The material used in these tampons are similar to those used in other legally marketed tampons in the US.
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K Number
K001641Device Name
TAMPONS
Manufacturer
ROSTAM LTD.
Date Cleared
2000-08-03
(65 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
ROSTAM LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K965064Device Name
ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON
Manufacturer
ROSTAM LTD.
Date Cleared
1997-02-20
(64 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
ROSTAM LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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