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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 K102936
Device Name HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
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 Received10/04/2010
Decision Date 03/30/2011
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
Recalls CDRH Recalls
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