The following data is part of a premarket notification filed by Roki Co., Ltd. with the FDA for Roki Surgical Mask.
Device ID | K214094 |
510k Number | K214094 |
Device Name: | ROKI Surgical Mask |
Classification | Mask, Surgical |
Applicant | ROKI Co., Ltd. 2396 Futamata, Futamata-Cho, Tenryu-ku Hamamatsu-shi, JP 431-3314 |
Contact | Takamasa Murata |
Correspondent | Fumiaki Kanai MIC International 4-32-16 Ryogoku Sumida-ku, JP |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-12-28 |
Decision Date | 2022-02-24 |