The following data is part of a premarket notification filed by Astell Scientific Limited with the FDA for Astell Umb 220, Umb 230, Umb 240 Autoclaves/sterilizers.
| Device ID | K170304 |
| 510k Number | K170304 |
| Device Name: | Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers |
| Classification | Sterilizer, Steam |
| Applicant | Astell Scientific Limited 19-21 Powerscroft Rd Sidcup, GB Da14 5dt |
| Contact | Gary Doughty |
| Correspondent | Gary Doughty Astell Scientific Limited 19-21 Powerscroft Rd Sidcup, GB Da14 5dt |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-31 |
| Decision Date | 2018-03-02 |
| Summary: | summary |