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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K926568
Device Name BAXTER CT DIALYZER
Applicant
BAXTER HEALTHCARE CORP.
1500 WAUKEGAN RD.
MCGAW PK,  IL  60085
Applicant Contact AMY STUEBER
Correspondent
BAXTER HEALTHCARE CORP.
1500 WAUKEGAN RD.
MCGAW PK,  IL  60085
Correspondent Contact AMY STUEBER
Regulation Number876.5860
Classification Product Code
KDI  
Date Received12/31/1992
Decision Date 09/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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