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