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FDA 510(k)

MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR

K-Number: K862852 · 1986-08-11

ApplicantMicro-Aire Surgical Instruments, Inc.
Decision Date1986-08-11
Product CodeGFF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Aire Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1986-08-11 under 510(k) number K862852. The device is classified under product code GFF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR?

MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR is a medical device that received FDA 510(k) clearance on 1986-08-11. The listed applicant is Micro-Aire Surgical Instruments, Inc.. The 510(k) number is K862852.

When did MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR receive FDA 510(k) clearance?

MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR received FDA 510(k) clearance on 1986-08-11, under 510(k) number K862852.

Who is the listed applicant for MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR?

The FDA 510(k) record lists Micro-Aire Surgical Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR?

The FDA product code for MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR is GFF.

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Other records listing Micro-Aire Surgical Instruments, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K904949A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERSK903713OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229K903650OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305K902676MICROGUARD, ORTHOPEDIC PIN PROTECTORSK903664MICRO-AIRE WIRE PASS AND CRANIOTOME DRILLK901967DENDIA WERK BURS AND CUTTING DISCS

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Related Devices (Code: GFF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K974025ANSPACH SHIELDED ATTACHMENTThe Anspach Effort, Inc.K950449SURGICAL BURTransidyne General Corp.K943758SURGICAL BURKomet MedicalK934583BURRSAmerican Medical Specialties, Inc.K894438MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTSMicro-Aire Surgical Instruments, Inc.K890090DANEK IRRIGATING BURR (DIB) SETDanek Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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