The following data is part of a premarket notification filed by Vericom Co., Ltd. with the FDA for Vonflex S.
| Device ID | K152615 |
| 510k Number | K152615 |
| Device Name: | Vonflex S |
| Classification | Material, Impression |
| 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 | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-14 |
| Decision Date | 2016-11-03 |
| Summary: | summary |