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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 K884401
Device Name SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT
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 01/12/1989
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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