FDA 510(k) Application Details - K031368

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K031368
Device Name	Surgeon'S Gloves
Applicant	CEPHAS MEDICAL PRIVATE LTD. B13 MADRAS EXPORT PROCESSING ZONE, TAMBARAM CHENNAI TAMILNADU 600 045 IN Other 510(k) Applications for this Company
Contact	THANGIAH IMMANUEL 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	04/30/2003
Decision Date	06/22/2004
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