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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 K893217
Device Name LATEX PROPHYLACTIC/RUBBER CONTRACEPTIVE
Applicant
Shinhen Corp.
Chung K. Kwak
3350 Wilshire Blvd., #378
Los Angeles,  CA  90010
Applicant Contact BNF ENTERPRISES
Correspondent
Shinhen Corp.
Chung K. Kwak
3350 Wilshire Blvd., #378
Los Angeles,  CA  90010
Correspondent Contact BNF ENTERPRISES
Regulation Number884.5300
Classification Product Code
HIS  
Date Received04/27/1989
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
Predetermined Change
Control Plan Authorized		 No
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