RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR


Device Classification Name

accessories, blood circuit, hemodialysis

510(k) Number K022536
Device Name RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR
Original Applicant
FRESENIUS MEDICAL CARE
95 hayden ave.
lexington, 
MA 
02420

Original Contact art eilinsfeld
Regulation Number 876.5820
Classification Product Code
KOC  
Date Received 08/01/2002
Decision Date 10/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls