MEGA BIG BOY CONDOM

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 Mega Big Boy Condom.

Pre-market Notification Details

Device IDK140379
510k NumberK140379
Device Name:MEGA BIG BOY CONDOM
ClassificationCondom
Applicant OKAMOTO U.S.A., INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington,  DC  20005
ContactJeffrey N Gibbs
CorrespondentJeffrey 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 Received2014-02-14
Decision Date2014-07-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00813356000439 K140379 000
00850002174564 K140379 000
00850002174557 K140379 000

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