FDA 510(k), K021481, BRESAGEN CATHETER, MODEL CS-3000

510(K) Number: K021481
Device Name: BRESAGEN CATHETER, MODEL CS-3000
Manufacturer: BRESAGEN, INC.
Device Classification Name: Catheter, Ventricular
Regulation Number: 882.4100
Classification Product Code: HCA
Date Received: 05/08/2002
Decision Date: 08/06/2002
Regulation Medical Specialty: Neurology

NOTES: Originally 301 pages that included 225 fully-redacted pages that have been removed from the file.