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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 K931077
Device Name LATEX PROPHYLACTIC RUBBER CONTRACEPTIVE
Applicant
J.K. CHEMICALS, LTD.
C/O BNF ENTERPRISES
3440 WILSHIRE BLVD., SUITE 229
LOS ANGELES,  CA  90010
Applicant Contact CHUNG K KWAK
Correspondent
J.K. CHEMICALS, LTD.
C/O BNF ENTERPRISES
3440 WILSHIRE BLVD., SUITE 229
LOS ANGELES,  CA  90010
Correspondent Contact CHUNG K KWAK
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/03/1993
Decision Date 09/14/1994
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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