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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K934803
Device Name ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS
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 Number876.5820
Classification Product Code
FJK  
Date Received10/20/1993
Decision Date 12/17/1993
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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