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FDA 510(k)

MICRO-AIRE OTO/NEURO DRILL SYSTEM

K-Number: K854331 · 1986-01-21

ApplicantMicro-Aire Surgical Instruments, Inc.
Decision Date1986-01-21
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MICRO-AIRE OTO/NEURO DRILL SYSTEM 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 1986-01-21 under 510(k) number K854331. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-AIRE OTO/NEURO DRILL SYSTEM?

MICRO-AIRE OTO/NEURO DRILL SYSTEM is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Micro-Aire Surgical Instruments, Inc.. The 510(k) number is K854331.

When did MICRO-AIRE OTO/NEURO DRILL SYSTEM receive FDA 510(k) clearance?

MICRO-AIRE OTO/NEURO DRILL SYSTEM received FDA 510(k) clearance on 1986-01-21, under 510(k) number K854331.

Who is the listed applicant for MICRO-AIRE OTO/NEURO DRILL SYSTEM?

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 OTO/NEURO DRILL SYSTEM?

The FDA product code for MICRO-AIRE OTO/NEURO DRILL SYSTEM is ERL.

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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 & 2500-229K902676MICROGUARD, ORTHOPEDIC PIN PROTECTORSK903650OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305K903664MICRO-AIRE WIRE PASS AND CRANIOTOME DRILLK901967DENDIA WERK BURS AND CUTTING DISCS

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Related Devices (Code: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation

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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