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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
PLAYTEX MANUFACTURING INC.
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
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?
Applicant Name (Manufacturer) :
PLAYTEX MANUFACTURING INC.
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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