Jetlite 4000
FDA 510(k) K000078 · J. Morita USA, Inc.
510(k) numberK000078
Submission
- Device name
- Jetlite 4000
- Applicant
- J. Morita USA, Inc.
Washington, DC, US - Received
- January 11, 2000
- Decision date
- May 15, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Jetlite 4000 cleared by the FDA?
Jetlite 4000 (K000078) received a 510(k) decision of Substantially Equivalent on May 15, 2000, 125 days after the submission was received.
What is the product code of K000078?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.