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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 K875111
Device Name RUBBER CONTRACEPTIVE, LATEX CONDOMS
Applicant
Okamoto USA, Inc.
18 King St.
Stratford,  CT  06615
Applicant Contact HISAYUKI NAITO
Correspondent
Okamoto USA, Inc.
18 King St.
Stratford,  CT  06615
Correspondent Contact HISAYUKI NAITO
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/14/1987
Decision Date 02/26/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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