FDA 510(k)

MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL

K-Number: K850597 · 1985-03-25

ApplicantMicro-Aire Surgical Instruments, Inc.

Decision Date1985-03-25

Product CodeEFB

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL 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 1985-03-25 under 510(k) number K850597. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL?

MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL is a medical device that received FDA 510(k) clearance on 1985-03-25. The listed applicant is Micro-Aire Surgical Instruments, Inc.. The 510(k) number is K850597.

When did MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL receive FDA 510(k) clearance?

MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL received FDA 510(k) clearance on 1985-03-25, under 510(k) number K850597.

Who is the listed applicant for MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL?

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 HIGH SPEED ORAL SURGERG DRILL?

The FDA product code for MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL is EFB.

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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.