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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 K896339
Device Name MODIFIED LABELING ON OKAMOTO HARMONY 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 Received11/03/1989
Decision Date 01/10/1990
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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