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FDA 510(k) Application Details - K024130
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K024130
Device Name
Surgeon'S Gloves
Applicant
WRP ASIA PACIFIC SDN. BHD.
LOT 1, JALAN 3,
KAWASAN PERUSAHAAN BANDAR BARU
SALAK TINGGI, SEPANG SELANGOR 43900 MY
Other 510(k) Applications for this Company
Contact
TERENCE LIN
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
12/16/2002
Decision Date
12/30/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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