Extremely Thin 003, ZERO ZERO THREE

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 Extremely Thin 003, Zero Zero Three.

Pre-market Notification Details

Device IDK192669
510k NumberK192669
Device Name:Extremely Thin 003, ZERO ZERO THREE
ClassificationCondom
Applicant Okamoto U.S.A., Inc. 18 King Street Stratford,  CT  06615
ContactYu Tadano
CorrespondentJeffrey N. Gibbs
Hyman, Phelps & McNamara, P.C. Washington,  DC  20005
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-25
Decision Date2020-07-24

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