TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM

Condom, Synthetic

CHURCH & DWIGHT CO., INC.

The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for Trojan Supra Lubricated Polyurethane Male Condom.

Pre-market Notification Details

Device IDK100767
510k NumberK100767
Device Name:TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
ClassificationCondom, Synthetic
Applicant CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET Princeton,  NJ  08543
ContactJoseph Ciccone
CorrespondentJoseph Ciccone
CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET Princeton,  NJ  08543
Product CodeMOL  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-18
Decision Date2011-04-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00022600902423 K100767 000
00022600902201 K100767 000

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