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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 K890315
Device Name CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G
Applicant
Baxter Healthcare Corp
Route 120 And Wilson Rd.
Round Lake,  IL  60073
Applicant Contact ROBERT L WILKINSON
Correspondent
Baxter Healthcare Corp
Route 120 And Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact ROBERT L WILKINSON
Regulation Number876.5860
Classification Product Code
KDI  
Date Received01/23/1989
Decision Date 02/08/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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