OKAMOTO ULTRA THIN

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 Okamoto Ultra Thin.

Pre-market Notification Details

Device IDK090259
510k NumberK090259
Device Name:OKAMOTO ULTRA THIN
ClassificationCondom
Applicant OKAMOTO U.S.A., INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington,  DC  20005
ContactJeffery N Gibbs
CorrespondentJeffery N Gibbs
OKAMOTO U.S.A., INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington,  DC  20005
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-02-02
Decision Date2009-03-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00813356000354 K090259 000
00813356000347 K090259 000
00813356000330 K090259 000
00850002174526 K090259 000
00850002174519 K090259 000
00850002174113 K090259 000
00850002174106 K090259 000
80022600001542 K090259 000
80022600001573 K090259 000

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