The following data is part of a premarket notification filed by Tso3 Inc with the FDA for Sterizone Vp4 Sterilizer.
Device ID | K172191 |
510k Number | K172191 |
Device Name: | STERIZONE VP4 Sterilizer |
Classification | Two Or More Sterilant Sterilizer |
Applicant | TSO3 Inc 2505 Avenue Dalton Quebec, CA G1p 3s5 |
Contact | Alexandre Jokic |
Correspondent | Cynthia G. Pritchard BioTechnology Transfer, LLC 1016 Tobiano Lane Raleigh, NC 27614 |
Product Code | PJJ |
CFR Regulation Number | 880.6860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-20 |
Decision Date | 2018-05-09 |
Summary: | summary |