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Found 2 results
510(k) Data Aggregation
K Number
K991047Device Name
HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)
Manufacturer
HARDCOVER PRODUCTS, INC.
Date Cleared
1999-06-18
(80 days)
Product Code
LTZ
Regulation Number
884.5310Why did this record match?
Applicant Name (Manufacturer) :
HARDCOVER PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These multiple-brand condoms are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases and HIV (AIDS).
Device Description
Not Found
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K Number
K990925Device Name
MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)
Manufacturer
HARDCOVER PRODUCTS, INC.
Date Cleared
1999-06-17
(90 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
HARDCOVER PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These multiple-brand condoms are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases and HIV (AIDS).
Device Description
Not Found
Ask a Question
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