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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 K053512
Device Name HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310
Applicant
Baxter Healthcare Corp
1620 Waukegan Rd.
Mcgaw Park,  IL  60085
Applicant Contact DAVID E CURTIN
Correspondent
Baxter Healthcare Corp
1620 Waukegan Rd.
Mcgaw Park,  IL  60085
Correspondent Contact DAVID E CURTIN
Regulation Number876.5630
Classification Product Code
FKX  
Date Received12/16/2005
Decision Date 02/16/2006
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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