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FDA 510(k) Application Details - K090066
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K090066
Device Name
Surgeon'S Gloves
Applicant
WEAR SAFE (MALAYSIA) SDN. BHD.
LOT PT 13726,JALAN HAJI SALLEH
OFF JALAN MERU
KLANG, SELANGOR 41050 MY
Other 510(k) Applications for this Company
Contact
S.H. TAM
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
01/09/2009
Decision Date
05/15/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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