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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 K896987
Device Name RUBBER CONDOM (NON-COLORED)
Applicant
Hankook Latex Gongup Co., Ltd.
C.P.O. Box 6739
Seoul, Korea,  KR
Applicant Contact DUKEE KWON
Correspondent
Hankook Latex Gongup Co., Ltd.
C.P.O. Box 6739
Seoul, Korea,  KR
Correspondent Contact DUKEE KWON
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/13/1989
Decision Date 06/06/1990
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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