FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR


Device Classification Name

set, administration, for peritoneal dialysis, disposable

510(k) Number K022412
Device Name FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
Original Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
95 hayden ave.
lexington, 
MA 
02420 -9192

Original Contact arthur e eilinsfeld
Regulation Number 876.5630
Classification Product Code
KDJ  
Date Received 07/24/2002
Decision Date 03/05/2003
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