RUBBER CONTRACEPTIVE, LATEX CONDOMS

Condom

OKAMOTO U.S.A., INC.

The following data is part of a premarket notification filed by Okamoto U.s.a., Inc. with the FDA for Rubber Contraceptive, Latex Condoms.

Pre-market Notification Details

Device IDK875111
510k NumberK875111
Device Name:RUBBER CONTRACEPTIVE, LATEX CONDOMS
ClassificationCondom
Applicant OKAMOTO U.S.A., INC. 18 KING ST. Stratford,  CT  06615
ContactHisayuki Naito
CorrespondentHisayuki Naito
OKAMOTO U.S.A., INC. 18 KING ST. Stratford,  CT  06615
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-14
Decision Date1988-02-26

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