FDA 510(k) Application Details - K973146

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K973146
Device Name	Drape, Surgical
Applicant	MENTOR OPHTHALMICS, INC. 5425 HOLLISTER AVE. SANTA BARBARA, CA 93111 US Other 510(k) Applications for this Company
Contact	DONNA A CRAWFORD Other 510(k) Applications for this Contact
Regulation Number	878.4370   More FDA Info for this Regulation Number
Classification Product Code	KKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/22/1997
Decision Date	12/04/1997
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