Piezotome 2
FDA 510(k) K091331 · Satelec
510(k) numberK091331
Submission
- Device name
- Piezotome 2
- Applicant
- Satelec
Mt. Laurel, NJ, US - Received
- May 5, 2009
- Decision date
- December 11, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Piezotome 2 cleared by the FDA?
Piezotome 2 (K091331) received a 510(k) decision of Substantially Equivalent on December 11, 2009, 220 days after the submission was received.
What is the product code of K091331?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.