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510(k) Data Aggregation
K Number
K971228Device Name
FEMTEX 100% COTTON TAMPONS
Manufacturer
Date Cleared
1997-04-09
(78 days)
Product Code
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
REGU-TECH ASSOC., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Femtex tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Device Description
Femtex 100% Cotton Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Tampons will be provided with 2 absorbencies, regular, and super. Femtex 100% Cotton Tampons are made from cotton and, cotton cord and sewing thread. The material used in Femtex tampons are similar to those used in other legally marketed tampons.
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K Number
K970232Device Name
FEMTEX 100% COTTON DENTLE TOUCH TAMPONS
Manufacturer
Date Cleared
1997-03-21
(59 days)
Product Code
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
REGU-TECH ASSOC., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Femtex 100% Cotton Gentle Touch tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Device Description
Femtex 100% Cotton Gentle Touch Tampons are menstrual tampons used to absorb menstrual fluid. Femtex 100% Cotton Gentle Touch Tampons will be provided with 2 absorbencies, regular and super.
Femtex 100% Cotton Gentle Touch Tampons are made from cotton absorbent, cotton cord and cotton sewing thread.
The material used in Femtex 100% Cotton Gentle Touch tampons are similar to those used in other legally marketed tampons.
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K Number
K963912Device Name
TYCO BABY SESAME STREET SOFT TEETHER
Manufacturer
Date Cleared
1996-11-06
(37 days)
Product Code
Regulation Number
872.5550Why did this record match?
Applicant Name (Manufacturer) :
REGU-TECH ASSOC., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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