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510(k) K152953

CRIT-LINE CLIP (CLIC) BLOOD CHAMBER by Fresenius Medical Care North America — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2015
Date Received
October 7, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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