FDA 510(k) Application Details - K983348

Device Classification Name	Gauze/Sponge, Internal   More FDA Info for this Device
510(K) Number	K983348
Device Name	Gauze/Sponge, Internal
Applicant	DYNAREX CORP. ONE INTERNATIONAL BLVD. BREWSTER, NY 10509 US Other 510(k) Applications for this Company
Contact	JOHN G MOULDEN 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	09/23/1998
Decision Date	12/11/1998
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