The following data is part of a premarket notification filed by Tso3 Inc. with the FDA for Sterizone Self-contained Biological Indicator.
| Device ID | K141580 |
| 510k Number | K141580 |
| Device Name: | STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | TSO3 INC. 512F NE 81ST STREET, SUITE 101 Vancouver, WA 98665 |
| Contact | Thomas Richards |
| Correspondent | Thomas Richards TSO3 INC. 512F NE 81ST STREET, SUITE 101 Vancouver, WA 98665 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-13 |
| Decision Date | 2014-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690455440201 | K141580 | 000 |
| 00690455426021 | K141580 | 000 |