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510(k) K124024

APD LUER-LOCK ADAPTER by Fresensius Medical Care North America — Product Code KDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2013
Date Received
December 28, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

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