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510(k) K853658

BURS FOR MICRO SURGICAL DRILL SYSTEM by Acumed Instruments Corp. — Product Code GFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1985
Date Received
September 3, 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 Acumed Instruments Corp.

  • K863627 — MICRO SURGICAL DRILL SYSTEM (October 2, 1986)
  • K853660 — MICRO SURGICAL DRILL SYSTEM (September 24, 1985)
  • K853659 — POWERED IRRIGATION FOR MICRO SURGICAL DRILL (September 24, 1985)
  • K791891 — ACU-MED RED MISER HEMOTHORAX BLOOD COLL. (December 5, 1979)
  • K791399 — ACU-ALERT (October 11, 1979)
  • K791400 — GASTRIC LAVAGE KIT-DISPOSABLE (August 16, 1979)
  • K790901 — I.V. TUBING ORGANIZER (June 27, 1979)

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)