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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 K854247
Device Name JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS
Applicant
M/S Seohung Industrial Co., Ltd.
U.S. Hwy. 190 & Colfax St.
P.O. Box 29
Cameron,  TX  76520
Applicant Contact MICHAEL D KIM
Correspondent
M/S Seohung Industrial Co., Ltd.
U.S. Hwy. 190 & Colfax St.
P.O. Box 29
Cameron,  TX  76520
Correspondent Contact MICHAEL D KIM
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/21/1985
Decision Date 01/16/1986
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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