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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 K970795
Device Name SHANG HO
Applicant
SHANG HO INDUSTRIAL CORP. LTD.
4-5 NAN PEI 1ST. RD.
CHIANG LI TACHIA
TAICHUNG HSIEN,  TW
Applicant Contact CHENG KO LIN
Correspondent
SHANG HO INDUSTRIAL CORP. LTD.
4-5 NAN PEI 1ST. RD.
CHIANG LI TACHIA
TAICHUNG HSIEN,  TW
Correspondent Contact CHENG KO LIN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/04/1997
Decision Date 12/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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