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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 K884402
Device Name EXTRA STRENGTH SKIN LESS SKIN CONDOM
Applicant
OKAMOTO U.S.A., INC.
1120 VERMONT AVE., N.W.
SUITE 600
WASHINGTON,  DC  20005
Applicant Contact JEFFREY N GIBBS
Correspondent
OKAMOTO U.S.A., INC.
1120 VERMONT AVE., N.W.
SUITE 600
WASHINGTON,  DC  20005
Correspondent Contact JEFFREY N GIBBS
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/19/1988
Decision Date 03/10/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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