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510(k) K821485

DERMABRADERS by Spire Medical, Inc. — Product Code GFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1982
Date Received
May 18, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bur, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Spire Medical, Inc.

  • K821487 — MICRO-SURGICAL POWER INSTRUMENT SYS. (July 2, 1982)
  • K821486 — MICRO DRILLS (June 9, 1982)
  • K802463 — MICRO-SURGICAL POWER INSTRUMENT SYSTEM (October 31, 1980)
  • K802503 — MICRO-SUGICAL POWER INSTRUMENT SYSTEM (October 31, 1980)

Other clearances for product code GFF

  • K974025 — ANSPACH SHIELDED ATTACHMENT (July 6, 1998)
  • K950449 — SURGICAL BUR (March 1, 1995)
  • K943758 — SURGICAL BUR (August 22, 1994)
  • K934583 — BURRS (January 26, 1994)
  • K894438 — MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS (August 21, 1989)
  • K890090 — DANEK IRRIGATING BURR (DIB) SET (January 24, 1989)
  • K883255 — KOMET SURGICAL BUR (September 15, 1988)
  • K880859 — SURGICAL BURS (March 21, 1988)
  • K880706 — SURGICAL BURS (February 26, 1988)
  • K872475 — SURGICAL BUR (July 2, 1987)