The following data is part of a premarket notification filed by Ts03 Inc with the FDA for Sterizone Vp4 Sterilizer.
| Device ID | K153392 |
| 510k Number | K153392 |
| Device Name: | STERIZONE VP4 Sterilizer |
| Classification | Two Or More Sterilant Sterilizer |
| Applicant | TS03 INC 2505, AVENUE DALTON Quebec, CA G1p 3s5 |
| Contact | Nathalie Racette |
| Correspondent | Thomas Richards IM3, INC 7720 NE Hwy 99 SUITE D #110 Vancouver, WA 98665 |
| Product Code | PJJ |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-24 |
| Decision Date | 2016-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690455045604 | K153392 | 000 |
| 00690455440003 | K153392 | 000 |