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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemodialyzer, Re-Use, High Flux
510(k) Number K970663
Device Name CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)
Applicant
Baxter Healthcare Corp
1620 Waulkegan Rd.
Mcgaw Park,  IL  60085
Applicant Contact ROBERT L WILKINSON
Correspondent
Baxter Healthcare Corp
1620 Waulkegan Rd.
Mcgaw Park,  IL  60085
Correspondent Contact ROBERT L WILKINSON
Regulation Number876.5860
Classification Product Code
MSF  
Date Received02/21/1997
Decision Date 01/11/1998
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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