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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K892922
Device Name LATEX SURGICAL GLOVES
Applicant
MILLIMAX CORP.
308-7 BUNPYUNG-DONG
CHEONG JU CITY, CHUNG BUK
SOUTH KOREA,  KR
Applicant Contact HWA-SUP, CHOE
Correspondent
MILLIMAX CORP.
308-7 BUNPYUNG-DONG
CHEONG JU CITY, CHUNG BUK
SOUTH KOREA,  KR
Correspondent Contact HWA-SUP, CHOE
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/12/1989
Decision Date 11/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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