Mi Varnish
FDA 510(k) K102808 · GC America, Inc.
510(k) numberK102808
Submission
- Device name
- Mi Varnish
- Applicant
- GC America, Inc.
Alsip, IL, US - Received
- September 28, 2010
- Decision date
- December 22, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Mi Varnish cleared by the FDA?
Mi Varnish (K102808) received a 510(k) decision of Substantially Equivalent on December 22, 2010, 85 days after the submission was received.
What is the product code of K102808?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.