The following data is part of a premarket notification filed by Tso3 Inc with the FDA for Sterizone Sterilizer.
Device ID | K153689 |
510k Number | K153689 |
Device Name: | STERIZONE Sterilizer |
Classification | Two Or More Sterilant Sterilizer |
Applicant | TSO3 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 | 2015-12-23 |
Decision Date | 2016-06-30 |
Summary: | summary |