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510(k) Data Aggregation
K Number
K962476Device Name
UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
Manufacturer
TAMBRANDS, INC.
Date Cleared
1996-08-13
(49 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
TAMBRANDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
unscented menstrual tampons used to absorb Intended Use: menstrual fluid.
Device Description
TAMPAX Tampons, Plastic Applicator will be provided in three absorbencies, regular, super and super plus. TAMPAX Tampons, Plastic Applicator have a colored plastic applicator. TAMPAX Tampons, Plastic Applicator are made of rayon fibers and overwrap, a cotton withdrawal cord, and a colored plastic applicator.
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K Number
K960341Device Name
TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS
Manufacturer
TAMBRANDS, INC.
Date Cleared
1996-04-17
(84 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
TAMBRANDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tampax Tampons with Additive are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Device Description
Tampons with Additive are menstrual tampons used to absorb menstrual fluid. Tampax Tampons with Additive will be provided in 4 absorbencies, junior, regular, super and super plus. Tampax Tampons with Additive are made of cotton and/or rayon fibers and overwrap, cotton cord, and an additive. The applicator used in Tampax tampons with Additive is flushable and biodegradable. Except for the additive, the materials used in Tampons with Additive are identical to those used in other legally marketed Tampax tampons. This additive has been adequately characterized and evaluated using scientifically valid safety tests.
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