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510(k) K880706

SURGICAL BURS by Nuell Air Equipment & Hospital Supplies, Inc. — Product Code GFF

K880706 is an FDA 510(k) premarket notification submitted by Nuell Air Equipment & Hospital Supplies, Inc. for the device "SURGICAL BURS". The FDA issued a decision of Substantially Equivalent on February 26, 1988. The device falls under product code GFF (Bur, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4820. Nuell Air Equipment & Hospital Supplies, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1988
Date Received
February 22, 1988
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 Nuell Air Equipment & Hospital Supplies, Inc.

  • K881418 — CRANIOTOME BLADE OR NEURO BLADE (May 31, 1988)
  • K880601 — WIRE PASS DRILL BITS (May 6, 1988)

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)
  • K872475 — SURGICAL BUR (July 2, 1987)
  • K862852 — MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR (August 11, 1986)

FDA data resources