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FDA 510(k) Application Details - K070619
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K070619
Device Name
Surgeon'S Gloves
Applicant
WRP ASIA PACIFIC SDN. BHD.
LOT1,JALAN3,KAWASAN PERUSAHAAN
BANDAR BARU SALAK TINGGI
SEPANG,SELANGOR DARUL EHSAN 43900 MY
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Contact
KIRK PENNER
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
03/05/2007
Decision Date
06/27/2007
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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