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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 K902804
Device Name EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT
Applicant
OKAMOTO U.S.A., INC.
JEFFREY N. GIBBS, SUITE 600
1120 VERMONT AVENUE, N.W.
WASHINGTON,  DC  20005
Applicant Contact & GIBBS
Correspondent
OKAMOTO U.S.A., INC.
JEFFREY N. GIBBS, SUITE 600
1120 VERMONT AVENUE, N.W.
WASHINGTON,  DC  20005
Correspondent Contact & GIBBS
Regulation Number884.5300
Classification Product Code
HIS  
Date Received06/27/1990
Decision Date 08/13/1990
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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