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FDA 510(k) Application Details - K001959
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K001959
Device Name
Surgeon'S Gloves
Applicant
HARTALEGA SDN BHD
9 JALAN KUANG BULAN TAMAN
KEPONG INDUSTRIAL ESTATE
KUALA LUMPUR 52100 MY
Other 510(k) Applications for this Company
Contact
NURU AISYAH KONG
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
06/27/2000
Decision Date
07/26/2000
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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