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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Semi-Automatic, Peritoneal
510(k) Number K874020
Device Name ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact FREDERICK GUSTAFSON
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact FREDERICK GUSTAFSON
Regulation Number876.5630
Classification Product Code
KPF  
Date Received10/02/1987
Decision Date 01/29/1988
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
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