FDA 510(k) Application Details - K974347

Device Classification Name	Gauze/Sponge, Internal   More FDA Info for this Device
510(K) Number	K974347
Device Name	Gauze/Sponge, Internal
Applicant	BALDUR SYSTEMS CORP. 3423 INVESTMENT BLVD., #12 HAYWARD, CA 94545 US Other 510(k) Applications for this Company
Contact	DAVID HU, PH.D. 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	11/19/1997
Decision Date	02/10/1998
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