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510(k) K850497

MICRO-AIRE GENERIC BURS & DRILLS by Micro-Aire Surgical Instruments, Inc. — Product Code GFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1985
Date Received
February 8, 1985
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 Micro-Aire Surgical Instruments, Inc.

  • K904949 — A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS (November 26, 1990)
  • K903650 — OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305 (September 14, 1990)
  • K903713 — OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 (September 14, 1990)
  • K902676 — MICROGUARD, ORTHOPEDIC PIN PROTECTORS (September 14, 1990)
  • K903664 — MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL (September 13, 1990)
  • K901967 — DENDIA WERK BURS AND CUTTING DISCS (July 13, 1990)
  • K901735 — ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444 (June 20, 1990)
  • K902168 — ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS) (June 20, 1990)
  • K900033 — MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS (February 13, 1990)
  • K900210 — BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 (February 2, 1990)

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)