FDA 510(k) Application Details - K970455

Device Classification Name	Gauze/Sponge, Internal   More FDA Info for this Device
510(K) Number	K970455
Device Name	Gauze/Sponge, Internal
Applicant	DUKAL CORP. 40178 U.S. 19 NORTH TARPON SPRINGS, FL 34689 US Other 510(k) Applications for this Company
Contact	PATRICK LAMB 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	02/06/1997
Decision Date	05/08/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review