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510(k) K974025

ANSPACH SHIELDED ATTACHMENT by The Anspach Effort, Inc. — Product Code GFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1998
Date Received
October 23, 1997
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

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Other clearances for product code GFF

  • 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)
  • K862852 — MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR (August 11, 1986)