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510(k) K012988

HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 by Baxter Healthcare Corp — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2001
Date Received
September 6, 2001
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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