V-varnish Premium
FDA 510(k) K160377 · Vericom Co., Ltd.
510(k) numberK160377
Submission
- Device name
- V-varnish Premium
- Applicant
- Vericom Co., Ltd.
Chuncheon-Si, KR - Received
- February 10, 2016
- Decision date
- December 2, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was V-varnish Premium cleared by the FDA?
V-varnish Premium (K160377) received a 510(k) decision of Substantially Equivalent on December 2, 2016, 296 days after the submission was received.
What is the product code of K160377?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.