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510(k) K951085

PADGETT AIR DERMATOME, MODEL A by Padgett Instruments, Inc. — Product Code GFD

K951085 is an FDA 510(k) premarket notification submitted by Padgett Instruments, Inc. for the device "PADGETT AIR DERMATOME, MODEL A". The FDA issued a decision of Substantially Equivalent on May 15, 1995. The device falls under product code GFD (Dermatome), a Class I device regulated under 21 CFR 878.4820. Padgett Instruments, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1995
Date Received
March 9, 1995
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 Padgett Instruments, Inc.

  • K770970 — HAIR TRANSPLANT PUNCH, MULTIPLH (October 27, 1977)

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)
  • 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