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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 K882498
Device Name EXTENDED LIFE CAPD TRANSFER SET 5C4444
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
KDJ  
Date Received06/17/1988
Decision Date 07/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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