The following data is part of a premarket notification filed by Shinva Medical Instrument Co., Ltd. with the FDA for Most-t Autoclave.
| Device ID | K220102 |
| 510k Number | K220102 |
| Device Name: | MOST-T Autoclave |
| Classification | Sterilizer, Steam |
| Applicant | Shinva Medical Instrument Co., Ltd. Xinhua Medical Scientific Zone, Zibo New & Hi-Tech Industrial Development Zone Zibo, CN 255086 |
| Contact | Liu Xiaolin |
| Correspondent | Olivia Meng Guangzhou Osmunda Medical Device Technology, Inc. 9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, CN 510006 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-12 |
| Decision Date | 2022-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970614967416 | K220102 | 000 |