FDA 510(k) Application Details - K971473

Device Classification Name	Gauze, External (With Drug/Biologic/Animal Source Material)   More FDA Info for this Device
510(K) Number	K971473
Device Name	Gauze, External (With Drug/Biologic/Animal Source Material)
Applicant	M-PACT WORLDWIDE MANAGEMENT CORP. 1040 O.C.L. PKWY. INTECH BUSINESS PK. EUDORA, KS 66025 US Other 510(k) Applications for this Company
Contact	BARRY HALE Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	GER Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/1997
Decision Date	07/07/1997
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