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510(k) K934583

BURRS by American Medical Specialties, Inc. — Product Code GFF

K934583 is an FDA 510(k) premarket notification submitted by American Medical Specialties, Inc. for the device "BURRS". The FDA issued a decision of Substantially Equivalent on January 26, 1994. The device falls under product code GFF (Bur, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4820. American Medical Specialties, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1994
Date Received
September 23, 1993
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 American Medical Specialties, Inc.

  • K960482 — K-WIRE (April 9, 1996)
  • K960483 — STEINMAN PIN (April 9, 1996)
  • K934603 — SURGICAL SAW BLADES (February 22, 1994)

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)
  • 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)

FDA data resources