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510(k) K981463

OMNITECH RESECTOSCOPE ROLLER ELECTRODE by Omnitech Systems, Inc. — Product Code KNF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1998
Date Received
April 23, 1998
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

Other clearances by Omnitech Systems, Inc.

  • K151976 — Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode (June 27, 2016)
  • K050454 — OMNITECH FULGURATING ELECTRODE (May 27, 2005)
  • K981464 — OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE (July 10, 1998)
  • K964365 — RESECTOSCOPE CUTTING LOOP ELECTRODE (April 22, 1997)
  • K965093 — OMNITECH RESECTOSCOPE ROLLER ELECTRODE (March 19, 1997)

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