Okamoto 002 Lubricated Polyurethane Male Condom

Condom, Synthetic

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 Okamoto 002 Lubricated Polyurethane Male Condom.

Pre-market Notification Details

Device IDK203541
510k NumberK203541
Device Name:Okamoto 002 Lubricated Polyurethane Male Condom
ClassificationCondom, Synthetic
Applicant Okamoto U.S.A. Inc. 18 King Street Stratford,  CT  06615
ContactYu Tadano
CorrespondentJeff N. Gibbs
Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street N.W. Suite 1200 Washington,  DC  20005
Product CodeMOL  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-03
Decision Date2022-02-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
80022600999832 K203541 000

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