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510(k) K191328

Megadyne Foot Switch by Megadyne Medical Products, Inc. — Product Code FYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2019
Date Received
May 16, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type

Other clearances by Megadyne Medical Products, Inc.

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  • K193145 — Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch (March 24, 2020)
  • K141587 — E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA F (February 18, 2015)
  • K133726 — MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE (January 24, 2014)
  • K080741 — MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE (December 16, 2008)
  • K081791 — E-Z CLEAN ELECTROSURGICAL ELECTRODE (October 21, 2008)
  • K072559 — SUCTION COAGULATOR (October 5, 2007)
  • K050579 — MEGA POWER ELECTROSURGICAL GENERATOR (March 24, 2005)

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