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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, for peritoneal dialysis, disposable
510(k) Number K902526
Device Name CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481
Applicant
BAXTER HEALTHCARE CORP.
ROUTE 120 AND WILSON RD.
ROUND LAKE,  IL  60073
Applicant Contact BONNIE J SMITH
Correspondent
BAXTER HEALTHCARE CORP.
ROUTE 120 AND WILSON RD.
ROUND LAKE,  IL  60073
Correspondent Contact BONNIE J SMITH
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received06/05/1990
Decision Date 11/20/1990
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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