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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom
510(k) Number K141256
Device Name OKAMOTO STUDDED CONDOM
Applicant
OKAMOTO U.S.A., INC.
700 THIRTEENTH STREET, N.W.
SUITE 1200
WASHINGTON,  DC  20005
Applicant Contact JOSEPH W CORMIER, JD, PHD
Correspondent
OKAMOTO U.S.A., INC.
700 THIRTEENTH STREET, N.W.
SUITE 1200
WASHINGTON,  DC  20005
Correspondent Contact JOSEPH W CORMIER, JD, PHD
Regulation Number884.5300
Classification Product Code
HIS  
Date Received05/14/2014
Decision Date 07/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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