FDA 510(k) Application Details - K970020

Device Classification Name	Gauze/Sponge, Internal   More FDA Info for this Device
510(K) Number	K970020
Device Name	Gauze/Sponge, Internal
Applicant	SIMAR, INC. 6800 LINDBERGH BLVD. PHILADELPHIA, PA 19142 US Other 510(k) Applications for this Company
Contact	FANG XI MEI 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	01/03/1997
Decision Date	03/20/1997
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