FDA 510(k) Application Details - K970341

Device Classification Name	Heparin Coating Chemicals   More FDA Info for this Device
510(K) Number	K970341
Device Name	Heparin Coating Chemicals
Applicant	MEDTRONIC PS MEDICAL 125 CREMONA DR. GOLETA, CA 93117-5500 US Other 510(k) Applications for this Company
Contact	TOM HOLDYCH Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/29/1997
Decision Date	04/23/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review