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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 K963933
Device Name PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
Applicant
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Applicant Contact ANN MARIE PAHLMAN
Correspondent
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Correspondent Contact ANN MARIE PAHLMAN
Regulation Number876.5820
Classification Product Code
FJI  
Date Received10/01/1996
Decision Date 11/24/1997
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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