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FDA 510(k) Application Details - K171276
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K171276
Device Name
Surgeon'S Gloves
Applicant
TG Medical SDN. BHD.
Lot 5091, Jalan Teratai
Batu 5, Off Jalan Meru
Klang 41050 MY
Other 510(k) Applications for this Company
Contact
Fatima Wati BT Mohamad
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
05/01/2017
Decision Date
08/21/2017
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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