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FDA 510(k) Application Details - K012479
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K012479
Device Name
Surgeon'S Gloves
Applicant
SMART GLOVE CORP. SDN BHD
LOT 6487 BATU 5 3/4
JALAN KAPAR
KLANG SELANGOR 42100 MY
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Contact
FOO KHON PU
Other 510(k) Applications for this Contact
Regulation Number
878.4460
More FDA Info for this Regulation Number
Classification Product Code
KGO
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More FDA Info for this Product Code
Date Received
08/02/2001
Decision Date
09/26/2001
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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