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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 K021615
Device Name BAXTER ACCURA SYSTEM, MODEL 5M5660
Applicant
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN RD., MPR-A2E
MCGAW PARK,  IL  60085 -6730
Applicant Contact DAVID E CURTIN
Correspondent
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN RD., MPR-A2E
MCGAW PARK,  IL  60085 -6730
Correspondent Contact DAVID E CURTIN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received05/16/2002
Decision Date 11/18/2002
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
Recalls CDRH Recalls
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