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FDA 510(k)

MICROAIRE SURGICAL INSTRUMENTS LLC

K-Number: K113128 · 2012-08-17

ApplicantMicroaire Surgical Instruments, LLC
Decision Date2012-08-17
Product CodeQPB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROAIRE SURGICAL INSTRUMENTS LLC is the device name listed in this FDA 510(k) record. The listed applicant is Microaire Surgical Instruments, LLC. It received FDA 510(k) clearance on 2012-08-17 under 510(k) number K113128. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROAIRE SURGICAL INSTRUMENTS LLC?

MICROAIRE SURGICAL INSTRUMENTS LLC is a medical device that received FDA 510(k) clearance on 2012-08-17. The listed applicant is Microaire Surgical Instruments, LLC. The 510(k) number is K113128.

When did MICROAIRE SURGICAL INSTRUMENTS LLC receive FDA 510(k) clearance?

MICROAIRE SURGICAL INSTRUMENTS LLC received FDA 510(k) clearance on 2012-08-17, under 510(k) number K113128.

Who is the listed applicant for MICROAIRE SURGICAL INSTRUMENTS LLC?

The FDA 510(k) record lists Microaire Surgical Instruments, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROAIRE SURGICAL INSTRUMENTS LLC?

The FDA product code for MICROAIRE SURGICAL INSTRUMENTS LLC is QPB.

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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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