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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, Capillary, Hollow Fiber
510(k) Number K980658
Device Name PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
Applicant
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Applicant Contact ROBERT L WILKINSON
Correspondent
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Correspondent Contact ROBERT L WILKINSON
Regulation Number876.5820
Classification Product Code
FJI  
Date Received02/19/1998
Decision Date 05/19/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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