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FDA 510(k) Application Details - K062764
Device Classification Name
Patient Examination Glove, Specialty
More FDA Info for this Device
510(K) Number
K062764
Device Name
Patient Examination Glove, Specialty
Applicant
KOSSAN LATEX INDUSTRIES(M)SDN BHD
LOT 6129,JALAN HAJI ABDUL
MANAN, OFF JALAN MERU
KLANG, SELANGOR 41050 MY
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Contact
LIM KWAN HWA
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/15/2006
Decision Date
02/27/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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