FDA 510(k) Application Details - K955505

Device Classification Name	Catheter, Irrigation   More FDA Info for this Device
510(K) Number	K955505
Device Name	Catheter, Irrigation
Applicant	NAVARRE BIOMEDICAL LTD. 2545 FERNBROOK LN. NORTH PLYMOUTH, MN 55447 US Other 510(k) Applications for this Company
Contact	KELLY BEHRENDT Other 510(k) Applications for this Contact
Regulation Number	878.4200   More FDA Info for this Regulation Number
Classification Product Code	GBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/1995
Decision Date	02/07/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review