FDA 510(k) Application Details - K971471

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K971471
Device Name	Surgeon'S Gloves
Applicant	ECI MEDICAL TECHNOLOGIES, INC. 2 COOK RD. BRIDGEWATER, NOVA SCOTIA B4V 3W7 CA Other 510(k) Applications for this Company
Contact	MICHAEL FORER 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	04/23/1997
Decision Date	02/09/1998
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