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FDA 510(k) Application Details - K014283
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K014283
Device Name
Surgeon'S Gloves
Applicant
BRIGHTWAY GLOVES PVT. LTD.
PIONEER MANIKANDAN BUILDINGS
VADASERY, NAGAR COIL
TAMIL NADU 629001 IN
Other 510(k) Applications for this Company
Contact
N. PARAMASIVAN
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
12/27/2001
Decision Date
05/22/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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