PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K011221
Device Name PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
Original Applicant
GAMBRO RENAL PRODUCTS
10810 w. collins ave.
lakewood, 
CO 
80215

Original Contact suzanne dennis
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 04/20/2001
Decision Date 10/31/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls