MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)

Condom

HARDCOVER PRODUCTS, INC.

The following data is part of a premarket notification filed by Hardcover Products, Inc. with the FDA for Male Natural Rubber Latex Condom (with Lubrication).

Pre-market Notification Details

Device IDK990925
510k NumberK990925
Device Name:MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)
ClassificationCondom
Applicant HARDCOVER PRODUCTS, INC. 55 ADMINISTRATION RD., UNIT 12 Concord, Ontario,  CA L4k 4g9
ContactGerry Glazer
CorrespondentGerry Glazer
HARDCOVER PRODUCTS, INC. 55 ADMINISTRATION RD., UNIT 12 Concord, Ontario,  CA L4k 4g9
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-19
Decision Date1999-06-17

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