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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K002210
Device Name SYNTRA DIALYZER, MODEL SYNTRA 120, 160
Applicant
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN RD., MPR-A2E
MCGAW PARK,  IL  60085 -6730
Applicant Contact ROBERT L WILKINSON
Correspondent
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN RD., MPR-A2E
MCGAW PARK,  IL  60085 -6730
Correspondent Contact ROBERT L WILKINSON
Regulation Number876.5860
Classification Product Code
KDI  
Date Received07/21/2000
Decision Date 02/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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