The following data is part of a premarket notification filed by Yozma Bmtech Co., Ltd. with the FDA for Frozen N.
| Device ID | K193665 |
| 510k Number | K193665 |
| Device Name: | Frozen N |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | Yozma BmTech Co., Ltd. #609, 808, 1001~1007, Jungang Induspia 5-cha, 137, Sagimakgol-ro, Jungwon-gu Seongnam-si, KR 13202 |
| Contact | Jenny Cho |
| Correspondent | Dave Kim MTech Group 7707 Fannin St. Ste 200 Houston, TX 77054 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-31 |
| Decision Date | 2020-05-28 |