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FDA 510(k)

MICRO-AIRE STERNUM SAW REPLACEMENT BLADES

K-Number: K850483 · 1985-03-01

ApplicantMicro-Aire Surgical Instruments, Inc.
Decision Date1985-03-01
Product CodeDWH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICRO-AIRE STERNUM SAW REPLACEMENT BLADES 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 1985-03-01 under 510(k) number K850483. The device is classified under product code DWH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-AIRE STERNUM SAW REPLACEMENT BLADES?

MICRO-AIRE STERNUM SAW REPLACEMENT BLADES is a medical device that received FDA 510(k) clearance on 1985-03-01. The listed applicant is Micro-Aire Surgical Instruments, Inc.. The 510(k) number is K850483.

When did MICRO-AIRE STERNUM SAW REPLACEMENT BLADES receive FDA 510(k) clearance?

MICRO-AIRE STERNUM SAW REPLACEMENT BLADES received FDA 510(k) clearance on 1985-03-01, under 510(k) number K850483.

Who is the listed applicant for MICRO-AIRE STERNUM SAW REPLACEMENT BLADES?

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 STERNUM SAW REPLACEMENT BLADES?

The FDA product code for MICRO-AIRE STERNUM SAW REPLACEMENT BLADES is DWH.

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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

View all 40 devices →

Related Devices (Code: DWH)

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.

K904352CODMAN COLLINS RADIOPARENT STERNAL BLADESCodman & Shurtleff, Inc.K862474HALL STERNUM SAWHall Surgical, Division of Zimmer, Inc.K830189CARDIOVASCULAR SAW BLADESTemp Medical Products, 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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