510(k) K070315

LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 by Lina Medical Aps — Product Code KNF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2007
Date Received
February 1, 2007
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