FDA 510(k) Application Details - K960055

Device Classification Name	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days   More FDA Info for this Device
510(K) Number	K960055
Device Name	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant	PUDENZ-SCHULTE MEDICAL RESEARCH CORP. UNIV BUSINESS CTR. 125 CREMONA DR. GOLETA, CA 93117 US Other 510(k) Applications for this Company
Contact	TOM HOLDYCH Other 510(k) Applications for this Contact
Regulation Number	880.5970   More FDA Info for this Regulation Number
Classification Product Code	LJS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/04/1996
Decision Date	09/30/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review