TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV


the company

Device Classification Name

accessories, blood circuit, hemodialysis

510(k) Number K002816
Device Name TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
Original Applicant
TRANSONIC SYSTEMS, INC.
34 dutch mill rd.
ithaca, 
NY 
14850

Original Contact mark s alsberge
Regulation Number 876.5820
Classification Product Code
KOC  
Date Received 09/11/2000
Decision Date 11/22/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No