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510(k) K861138

MASH DERMATOME by Mecron Medical Products, Inc. — Product Code GFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1986
Date Received
March 26, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dermatome
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Mecron Medical Products, Inc.

  • K854191 — MECRON UNCEMENTED STRUCTURED STEM HIP (November 13, 1985)
  • K844775 — EFFNER-EYE CAUTERY WITH BATTERY HANDLE (August 12, 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 GFD

  • K965256 — DMS-1000C DERMOABRADER (December 9, 1996)
  • K962371 — DERMTOME BLADE (August 29, 1996)
  • K945594 — DECA DERMATOME (MICROMOTOR SYSTEM) (June 5, 1995)
  • K951085 — PADGETT AIR DERMATOME, MODEL A (May 15, 1995)
  • K940208 — AESCULAP ACCU-DERMATOME (February 24, 1994)
  • K862669 — ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST (October 3, 1986)
  • K861285 — SKIN MESH DEVICE (April 17, 1986)
  • K860925 — DERMASPANDERE (March 28, 1986)
  • K842702 — ROSENBERG SKIN GRAFTING KNIVES (August 2, 1984)
  • K830993 — AMPLIGREFFE (May 3, 1983)