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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 K012988
Device Name HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
Applicant
Baxter Healthcare Corp
1620 Waukegan Rd., Mpr-A2e
Mcgaw Park,  IL  60085
Applicant Contact DAVID E CURTIN
Correspondent
Baxter Healthcare Corp
1620 Waukegan Rd., Mpr-A2e
Mcgaw Park,  IL  60085
Correspondent Contact DAVID E CURTIN
Regulation Number876.5630
Classification Product Code
FKX  
Date Received09/06/2001
Decision Date 12/05/2001
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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