OKAMOTO STUDDED 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 Okamoto Studded Condom.

Pre-market Notification Details

Device IDK141256
510k NumberK141256
Device Name:OKAMOTO STUDDED CONDOM
ClassificationCondom
Applicant OKAMOTO U.S.A., INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington,  DC  20005
ContactJoseph W Cormier, Jd, Phd
CorrespondentJoseph W Cormier, Jd, Phd
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 Received2014-05-14
Decision Date2014-07-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00813356000385 K141256 000

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