TROJAN FOR WOMEN LATEX CONDOMS W/SPERMI. MODIFIED

Condom

CARTER PRODUCTS

The following data is part of a premarket notification filed by Carter Products with the FDA for Trojan For Women Latex Condoms W/spermi. Modified.

Pre-market Notification Details

Device IDK901200
510k NumberK901200
Device Name:TROJAN FOR WOMEN LATEX CONDOMS W/SPERMI. MODIFIED
ClassificationCondom
Applicant CARTER PRODUCTS HALF ACRE RD. Cranbury,  NJ  08512
ContactC Kolakowsky
CorrespondentC Kolakowsky
CARTER PRODUCTS HALF ACRE RD. Cranbury,  NJ  08512
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-12
Decision Date1990-04-16

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