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510(k) K122593

PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 by Optim, LLC — Product Code FEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2012
Date Received
August 24, 2012
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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  • K130489 — ELECTRODE, FLEXIBLE SUCTION COAGULATOR (April 19, 2013)
  • K091829 — PLS PORTABLE LIGHT SOURCE (July 28, 2009)
  • K080622 — ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 (April 2, 2008)

Other clearances for product code FEH

  • K130489 — ELECTRODE, FLEXIBLE SUCTION COAGULATOR (April 19, 2013)
  • K803214 — ACMI BIPOLAR HEMOSTATIC ELECTRODE (January 15, 1981)