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510(k) K844774

EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS by Mecron Medical Products, Inc. — Product Code FCR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1985
Date Received
December 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Photographic, Fiberoptic
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Mecron Medical Products, Inc.

  • K861138 — MASH DERMATOME (April 14, 1986)
  • K854191 — MECRON UNCEMENTED STRUCTURED STEM HIP (November 13, 1985)
  • K844775 — EFFNER-EYE CAUTERY WITH BATTERY HANDLE (August 12, 1985)
  • K844488 — MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS (March 12, 1985)
  • K844487 — MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR (February 19, 1985)
  • K844486 — MECRON MRC-HEADLESS FEMORAL COMPONENT (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 FCR

  • K821754 — A O FIBER OPTIC ILLUMINATOR, 1185B (June 24, 1982)
  • K821753 — A O FIBER OPTIC ILLUMINATION, 1185A (June 24, 1982)