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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 K150857
Device Name Banana Gold
Applicant
HANKOOK LATEX GONGUP CO., LTD.
61, SAKJU-RO 145BEON-GIL
CHUNCHEON-SI,  KR 200-060
Applicant Contact KWON DUKEE
Correspondent
ONBIX CORPORATION
#821 SAMIL PLAZA
837-26 YEUKSAM-DONG
GANGNAM-GU,  KR 135-768
Correspondent Contact YANG HO DONG
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/31/2015
Decision Date 08/14/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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