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510(k) K121599

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2012
Date Received
June 1, 2012
Clearance Type
Traditional
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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