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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 K872812
Device Name SKINLESS-SKIN, PINK TINT (CONDOM)
Applicant
OKAMOTO U.S.A., INC.
18 KING ST.
STRATFORD,  CT  06615
Applicant Contact NAITO
Correspondent
OKAMOTO U.S.A., INC.
18 KING ST.
STRATFORD,  CT  06615
Correspondent Contact NAITO
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/16/1987
Decision Date 11/05/1987
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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