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FDA 510(k) Application Details - K954002
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K954002
Device Name
Surgeon'S Gloves
Applicant
AMPRI RUBBERWARE INDUSTRIES SDN BHD
LOT 10, UNIT TYPE A, KAWASAN
MIEL PHASE II 4300 BATANG KALI
SELANGOR MY
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Contact
MAY PHNG
Other 510(k) Applications for this Contact
Regulation Number
878.4460
More FDA Info for this Regulation Number
Classification Product Code
KGO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/25/1995
Decision Date
01/29/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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