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FDA 510(k) Application Details - K993756
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K993756
Device Name
Surgeon'S Gloves
Applicant
PAMITEX INDUSTRIES SDN BHD
2 1/2 MILES, JALAN RASAH
SEREMBAN, NAGERI SEMBILAN
DARUL KHUSUS 70300 MY
Other 510(k) Applications for this Company
Contact
SAID AWANG
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
11/05/1999
Decision Date
04/28/2000
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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