The following data is part of a premarket notification filed by Toul Meditech Ab with the FDA for Steristay.
| Device ID | K190027 |
| 510k Number | K190027 |
| Device Name: | SteriStay |
| Classification | Air Filter Portable Apparatus |
| Applicant | Toul Meditech AB Tunbytorpsgatan 31 Vasteras, SE 72137 |
| Contact | Tomas Hansson |
| Correspondent | Tomas Hansson Toul Meditech AB Tunbytorpsgatan 31 Vasteras, SE 72137 |
| Product Code | ORC |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-07 |
| Decision Date | 2019-05-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STERISTAY 79115797 4303380 Live/Registered |
Toul Meditech AB 2012-05-18 |