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FDA 510(k) Application Details - K033564
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K033564
Device Name
Surgeon'S Gloves
Applicant
KANAM LATEX INDUSTRIES PVT. LTD.
OPPOOTTIL BUILDING
P.O. BOX #28 K.K.ROAD
KOTTAYAM, KERALA 686001 IN
Other 510(k) Applications for this Company
Contact
RAVI ABRAHAM
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
11/12/2003
Decision Date
02/24/2004
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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