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510(k) K102936

HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R by Baxter Healthcare Corp — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2011
Date Received
October 4, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

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