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510(k) K132135

LINA GOLD LOOP HC by Lina Medical Aps — Product Code KNF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2014
Date Received
July 10, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
Submission Type

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