FDA 510(k) Application Details - K964722

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K964722
Device Name	Mask, Surgical
Applicant	RACAL FILTER TECHNOLOGIES, INC. 1360 CALIFORNIA AVENUE P.O. BOX 665 BROCKVILLE, ONTARIO K6V 5V8 CA Other 510(k) Applications for this Company
Contact	JOHN CAMPBELL Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FXX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/1996
Decision Date	02/07/1997
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