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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Peritoneal, Automatic Delivery
510(k) Number K884554
Device Name PERITONEAL CATHETER STABILIZATION DEVICE 5C4381
Applicant
BAXTER HEALTHCARE CORP.
ROUTE 120 AND WILSON RD.
ROUND LAKE,  IL  60073
Applicant Contact ROBERT L WILKINSON
Correspondent
BAXTER HEALTHCARE CORP.
ROUTE 120 AND WILSON RD.
ROUND LAKE,  IL  60073
Correspondent Contact ROBERT L WILKINSON
Regulation Number876.5630
Classification Product Code
FKX  
Date Received10/31/1988
Decision Date 01/31/1989
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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