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510(k) K130489

ELECTRODE, FLEXIBLE SUCTION COAGULATOR by Optim, LLC — Product Code FEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2013
Date Received
February 25, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Flexible Suction Coagulator
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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Other clearances for product code FEH

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  • K803214 — ACMI BIPOLAR HEMOSTATIC ELECTRODE (January 15, 1981)