BAXTER ACCURA SYSTEM, MODEL 5M5660


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K021615
Device Name BAXTER ACCURA SYSTEM, MODEL 5M5660
Original Applicant
BAXTER HEALTHCARE CORP.
1620 waukegan rd., mpr-a2e
mcgaw park, 
IL 
60085 -6730

Original Contact david e curtin
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 05/16/2002
Decision Date 11/18/2002
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