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FDA 510(k) Application Details - K201748
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K201748
Device Name
Surgeon'S Gloves
Applicant
Hartalega SDN BHD
Dataran SD PJU 9
Bandar Sri Damansara 52200 MY
Other 510(k) Applications for this Company
Contact
Kuan Kam Hon
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
06/26/2020
Decision Date
10/02/2020
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
Y
Expedited Review
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