PRISMAFLEX M150 SET


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K080519
Device Name PRISMAFLEX M150 SET
Applicant
GAMBRO RENAL PRODUCTS, INC.
14143 denver west parkway
suite 400
lakewood, 
CO 
80401

Applicant Contact kae miller
Correspondent
GAMBRO RENAL PRODUCTS, INC.
14143 denver west parkway
suite 400
lakewood, 
CO 
80401

Correspodent Contact kae miller
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 02/25/2008
Decision Date 06/13/2008
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