The following data is part of a premarket notification filed by Tso3 Inc. with the FDA for Sterizone Chemical Indicator.
| Device ID | K141698 |
| 510k Number | K141698 |
| Device Name: | STERIZONE CHEMICAL INDICATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | TSO3 INC. 512F NE 81ST STREET, SUITE 110 Vancouver, WA 98665 |
| Contact | Thomas Richards, Ph.d. |
| Correspondent | Thomas Richards, Ph.d. TSO3 INC. 512F NE 81ST STREET, SUITE 110 Vancouver, WA 98665 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-24 |
| Decision Date | 2014-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690455438109 | K141698 | 000 |