FDA 510(k) Application Details - K973511

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K973511
Device Name	Dressing, Wound, Drug
Applicant	KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. MANSFIELD, MA 02048 US Other 510(k) Applications for this Company
Contact	DAVID A OLSON Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/1997
Decision Date	12/16/1997
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review