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 |