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510(k) K962371

DERMTOME BLADE by Dsp Worldwide — Product Code GFD

K962371 is an FDA 510(k) premarket notification submitted by Dsp Worldwide for the device "DERMTOME BLADE". The FDA issued a decision of Substantially Equivalent on August 29, 1996. The device falls under product code GFD (Dermatome), a Class I device regulated under 21 CFR 878.4820. Dsp Worldwide has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1996
Date Received
June 19, 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 Dsp Worldwide

  • K962544 — MICRO DIAMOND-POINT DISSECTION NEEDLES (September 20, 1996)
  • K962365 — XENON LIGHTSOURCE (July 18, 1996)

Other clearances for product code GFD

  • K965256 — DMS-1000C DERMOABRADER (December 9, 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