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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Finger Cot
510(k) Number K903073
Device Name LATEX FINGER COTS
Applicant
Dongkuk Trading Co., Ltd.
K.P.O Box 150
Seoul, Korea,  KR
Applicant Contact H. S PARK
Correspondent
Dongkuk Trading Co., Ltd.
K.P.O Box 150
Seoul, Korea,  KR
Correspondent Contact H. S PARK
Regulation Number880.6250
Classification Product Code
LZB  
Date Received07/12/1990
Decision Date 09/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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