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510(k) K844775

EFFNER-EYE CAUTERY WITH BATTERY HANDLE by Mecron Medical Products, Inc. — Product Code HQO

K844775 is an FDA 510(k) premarket notification submitted by Mecron Medical Products, Inc. for the device "EFFNER-EYE CAUTERY WITH BATTERY HANDLE". The FDA issued a decision of Substantially Equivalent on August 12, 1985. The device falls under product code HQO (Unit, Cautery, Thermal, Ac-Powered), a Class II device regulated under 21 CFR 886.4115. Mecron Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1985
Date Received
December 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cautery, Thermal, Ac-Powered
Device Class
Class II
Regulation Number
886.4115
Review Panel
OP
Submission Type

Other clearances by Mecron Medical Products, Inc.

  • K861138 — MASH DERMATOME (April 14, 1986)
  • K854191 — MECRON UNCEMENTED STRUCTURED STEM HIP (November 13, 1985)
  • K844774 — EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS (April 22, 1985)
  • K844488 — MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS (March 12, 1985)
  • K844486 — MECRON MRC-HEADLESS FEMORAL COMPONENT (February 19, 1985)
  • K844487 — MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR (February 19, 1985)
  • K844773 — EFF-EFFNER BULBS (January 8, 1985)
  • K843449 — AUTODYNAMIC COMPRESSION HIP SCREW-PLATE (October 22, 1984)
  • K843553 — BONE PLATES (October 1, 1984)
  • K843554 — BONE SCREWS (October 1, 1984)

Other clearances for product code HQO

  • K070871 — STARION UNIVERSAL POWER SUPPLY (April 13, 2007)
  • K043155 — STARION UNIVERSAL POWER SUPPLY (UPS) (December 9, 2004)
  • K002341 — THERMAL CAUTERY UNIT, MODEL 150 (October 23, 2000)
  • K000893 — AC POWERED THERMAL CAUTERY UNIT (June 14, 2000)
  • K971538 — MENTOR GEMINI HEMOSTATIC ERASER (July 14, 1997)
  • K962135 — D.O.R.C. MICRODIATHERMY SYSTEM (August 29, 1996)
  • K943031 — BIPOLAR ELECTROSURGICAL PENCIL (September 23, 1994)
  • K900913 — ADLER DISPOSABLE BIPOLAR CORD (April 4, 1990)
  • K874367 — VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF (January 4, 1988)
  • K852075 — SITE-MALIS BIPOLAR COAGULATOR MODULE (August 20, 1985)

FDA data resources