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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K990677
Device Name ABSOGEL CHEMOTHERAPHY GLOVES
Applicant
AMPRI RUBBERWARE INDUSTRIES SDN BHD
LOT B5 & B6, PHASE II,
KAWASAN PERINDUSTRIAN MIEL
BATANG KALI, SELANGOR,  MY 44300
Applicant Contact LI KIM PHNG
Correspondent
AMPRI RUBBERWARE INDUSTRIES SDN BHD
LOT B5 & B6, PHASE II,
KAWASAN PERINDUSTRIAN MIEL
BATANG KALI, SELANGOR,  MY 44300
Correspondent Contact LI KIM PHNG
Regulation Number880.6250
Classification Product Code
LZC  
Date Received03/02/1999
Decision Date 11/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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