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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K911315
Device Name EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT
Applicant
Baxter Healthcare Corp
Rte. 120 And Wilson Rd.
Round Lake,  IL  60073
Applicant Contact BONNIE J SMITH
Correspondent
Baxter Healthcare Corp
Rte. 120 And Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact BONNIE J SMITH
Regulation Number876.5820
Classification Product Code
KOC  
Date Received03/26/1991
Decision Date 10/30/1991
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
Recalls CDRH Recalls
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