FDA 510(k) Application Details - K974295

Device Classification Name	Accessories, Catheter   More FDA Info for this Device
510(K) Number	K974295
Device Name	Accessories, Catheter
Applicant	BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 TUCSON, AZ 85706 US Other 510(k) Applications for this Company
Contact	TODD LANE Other 510(k) Applications for this Contact
Regulation Number	878.4200   More FDA Info for this Regulation Number
Classification Product Code	KGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/1997
Decision Date	02/10/1998
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