Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55
FDA 510(k) K042434 · Nouvag AG
510(k) numberK042434
Submission
- Device name
- Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55
- Applicant
- Nouvag AG
Gebenstorf, CH - Received
- September 8, 2004
- Decision date
- November 3, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55 cleared by the FDA?
Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55 (K042434) received a 510(k) decision of Substantially Equivalent on November 3, 2004, 56 days after the submission was received.
What is the product code of K042434?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.