Flexi-Lume LED System
FDA 510(k) K140281 · Epic Medical Concepts & Innovations
510(k) numberK140281
Submission
- Device name
- Flexi-Lume LED System
- Applicant
- Epic Medical Concepts & Innovations
Mission, KS, US - Received
- February 4, 2014
- Decision date
- July 24, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Flexi-Lume LED System cleared by the FDA?
Flexi-Lume LED System (K140281) received a 510(k) decision of Substantially Equivalent on July 24, 2014, 170 days after the submission was received.
What is the product code of K140281?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.