Microaire 1000E System
FDA 510(k) K014060 · Microaire Surgical Instruments, Inc.
510(k) numberK014060
Submission
- Device name
- Microaire 1000E System
- Applicant
- Microaire Surgical Instruments, Inc.
Charlottesville, VA, US - Received
- December 10, 2001
- Decision date
- March 5, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Microaire 1000E System cleared by the FDA?
Microaire 1000E System (K014060) received a 510(k) decision of Substantially Equivalent on March 5, 2002, 85 days after the submission was received.
What is the product code of K014060?
The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.