The following data is part of a premarket notification filed by Vericom Co., Ltd. with the FDA for V-varnish Premium.
| Device ID | K160377 |
| 510k Number | K160377 |
| Device Name: | V-varnish Premium |
| Classification | Varnish, Cavity |
| Applicant | Vericom Co., Ltd. 48 Toegyegongdan 1-gil, Chuncheon-si, KR 200-944 |
| Contact | Myung-hwan Oh |
| Correspondent | Myung-hwan Oh Vericom Co., Ltd. 48 Toegyegongdan 1-gil, Chuncheon-si, KR 200-944 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-10 |
| Decision Date | 2016-12-02 |
| Summary: | summary |