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FDA 510(k) Application Details - K991950
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K991950
Device Name
Surgeon'S Gloves
Applicant
LAGLOVE (M) SDN. BHD.
JALAN SIMPANG BALAK, OFF BATU
13, JALAN CHERAS, 43000 KAJANG
SELANGOR DARUL EHSAN MALA MG
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Contact
G. BASKARAN
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
06/09/1999
Decision Date
08/12/1999
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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