TCM Endo V, Model 1534
FDA 510(k) K042822 · Nouvag AG
510(k) numberK042822
Submission
- Device name
- TCM Endo V, Model 1534
- Applicant
- Nouvag AG
Gebenstorf, CH - Received
- October 12, 2004
- Decision date
- December 22, 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 TCM Endo V, Model 1534 cleared by the FDA?
TCM Endo V, Model 1534 (K042822) received a 510(k) decision of Substantially Equivalent on December 22, 2004, 71 days after the submission was received.
What is the product code of K042822?
The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.