Compalux Stroboscopic Light Polymerization Device
FDA 510(k) K912994 · Wilde-USA, Inc.
510(k) numberK912994
Submission
- Device name
- Compalux Stroboscopic Light Polymerization Device
- Applicant
- Wilde-USA, Inc.
Naperville, IL, US - Received
- July 8, 1991
- Decision date
- December 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Compalux Stroboscopic Light Polymerization Device cleared by the FDA?
Compalux Stroboscopic Light Polymerization Device (K912994) received a 510(k) decision of Substantially Equivalent on December 23, 1991, 168 days after the submission was received.
What is the product code of K912994?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.