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 |