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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 K883409
Device Name AEGIS(TM) CONDOMS
Applicant
Green Cross Medical Supplies Corp.
1443-10 Seocho-Dong, Seocho-
Ku
Seoul,  KR
Applicant Contact HOON KIM
Correspondent
Green Cross Medical Supplies Corp.
1443-10 Seocho-Dong, Seocho-
Ku
Seoul,  KR
Correspondent Contact HOON KIM
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/15/1988
Decision Date 03/13/1989
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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