FDA 510(k)

MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL

K-Number: K903664 · 1990-09-13

ApplicantMicro-Aire Surgical Instruments, Inc.

Decision Date1990-09-13

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MICRO-AIRE WIRE PASS AND CRANIOTOME 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 1990-09-13 under 510(k) number K903664. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL?

MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL is a medical device that received FDA 510(k) clearance on 1990-09-13. The listed applicant is Micro-Aire Surgical Instruments, Inc.. The 510(k) number is K903664.

When did MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL receive FDA 510(k) clearance?

MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL received FDA 510(k) clearance on 1990-09-13, under 510(k) number K903664.

Who is the listed applicant for MICRO-AIRE WIRE PASS AND CRANIOTOME 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 WIRE PASS AND CRANIOTOME DRILL?

The FDA product code for MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL is HBE.

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

K904949A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS K903713OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 K902676MICROGUARD, ORTHOPEDIC PIN PROTECTORS K903650OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305 K901967DENDIA WERK BURS AND CUTTING DISCS K901735ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444

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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.