FDA 510(k) Application Details - K971075

Device Classification Name	Gauze/Sponge, Internal   More FDA Info for this Device
510(K) Number	K971075
Device Name	Gauze/Sponge, Internal
Applicant	PRIMELINE MEDICAL PRODUCTS, INC. 2235-27TH AVENUE, N.E. CALGARY ALBERTA T2E 7M4 CA Other 510(k) Applications for this Company
Contact	GUY PLAMONDON Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	EFQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/1997
Decision Date	06/22/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review