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 |