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510(k) K945594

DECA DERMATOME (MICROMOTOR SYSTEM) by Depuy Intl., Ltd. — Product Code GFD

K945594 is an FDA 510(k) premarket notification submitted by Depuy Intl., Ltd. for the device "DECA DERMATOME (MICROMOTOR SYSTEM)". The FDA issued a decision of Substantially Equivalent on June 5, 1995. The device falls under product code GFD (Dermatome), a Class I device regulated under 21 CFR 878.4820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1995
Date Received
November 14, 1994
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 for product code GFD

  • K965256 — DMS-1000C DERMOABRADER (December 9, 1996)
  • K962371 — DERMTOME BLADE (August 29, 1996)
  • 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