Mini L.E.D. Oem Module
FDA 510(k) K040808 · Satelec
510(k) numberK040808
Submission
- Device name
- Mini L.E.D. Oem Module
- Applicant
- Satelec
Wellesley, MA, US - Received
- March 29, 2004
- Decision date
- April 28, 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 Mini L.E.D. Oem Module cleared by the FDA?
Mini L.E.D. Oem Module (K040808) received a 510(k) decision of Substantially Equivalent on April 28, 2004, 30 days after the submission was received.
What is the product code of K040808?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.