BRESAGEN CATHETER, MODEL CS-3000


Device Classification Name

catheter, ventricular

510(k) Number K021481
Device Name BRESAGEN CATHETER, MODEL CS-3000
Original Applicant
BRESAGEN, INC.
111 river bend rd.
athens, 
GA 
30605

Original Contact john kucharczyk
Regulation Number 882.4100
Classification Product Code
HCA  
Date Received 05/08/2002
Decision Date 08/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No