SYNTRA + DIALYZER, MODEL 200


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K023664
Device Name SYNTRA + DIALYZER, MODEL 200
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 10/31/2002
Decision Date 02/21/2003
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