Ascent F-Coat Model: 006-00097
FDA 510(k) K100540 · CAO Group, Inc.
510(k) numberK100540
Submission
- Device name
- Ascent F-Coat Model: 006-00097
- Applicant
- CAO Group, Inc.
West Jordan, UT, US - Received
- February 25, 2010
- Decision date
- September 23, 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 Ascent F-Coat Model: 006-00097 cleared by the FDA?
Ascent F-Coat Model: 006-00097 (K100540) received a 510(k) decision of Substantially Equivalent on September 23, 2010, 210 days after the submission was received.
What is the product code of K100540?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.