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510(k) K965256

DMS-1000C DERMOABRADER by Mattioli Engineering, Srl — Product Code GFD

K965256 is an FDA 510(k) premarket notification submitted by Mattioli Engineering, Srl for the device "DMS-1000C DERMOABRADER". The FDA issued a decision of Substantially Equivalent on December 9, 1996. The device falls under product code GFD (Dermatome), a Class I device regulated under 21 CFR 878.4820. Mattioli Engineering, Srl has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1996
Date Received
August 16, 1996
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 Mattioli Engineering, Srl

  • K100053 — MATTIOLI PULSE TWO/THREE PLUS FAMILY (March 10, 2010)
  • K042590 — TRANSDERM IONTO SYSTEM, MK 2 (October 14, 2004)
  • K032968 — TRSANSDERM IONTO SYSTEM (December 2, 2003)
  • K941838 — MULTIPLE CO2 LAERS (December 15, 1994)

Other clearances for product code GFD

  • 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)
  • K861138 — MASH DERMATOME (April 14, 1986)
  • K860925 — DERMASPANDERE (March 28, 1986)
  • K842702 — ROSENBERG SKIN GRAFTING KNIVES (August 2, 1984)
  • K830993 — AMPLIGREFFE (May 3, 1983)

FDA data resources