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FDA 510(k) Application Details - K993450
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K993450
Device Name
Surgeon'S Gloves
Applicant
FITCO DIPPED PRODUCTS PVT. LTD
14-A COCHIN EXPORT PROCESSING
ZONE, KAKKANAND, COCHIN
KERALA 682 030 IN
Other 510(k) Applications for this Company
Contact
JOSEPH PEREIRA
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
10/12/1999
Decision Date
12/29/1999
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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