510(k) K190260
- Device
- STERIZONE(R) VP4 Sterilizer
- Applicant
- TSO3 Inc
- 510(k) number
- K190260
- Product code
- PJJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-07-19
- Date received
- 2019-02-08
- Regulation
- 880.6860
- Classification name
- Two Or More Sterilant Sterilizer
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sandy Cliche
- Address
- 2505 Ave. Dalton Quebec CA G1P 3S5 G1P 3S5
Source Documents#
Other 510(k) Records For Product Code PJJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172191 | STERIZONE VP4 Sterilizer | Tso3, Inc. | 2018-05-09 |
| K173694 | STERIZONE VP4 Sterilizer | Tso3, Inc. | 2018-03-13 |
| K153689 | STERIZONE Sterilizer | Tso3, Inc. | 2016-06-30 |
| K153392 | STERIZONE VP4 Sterilizer | Ts03, Inc. | 2016-03-24 |
| K141163 | STERIZONE STERILIZER | Tso3, Inc. | 2014-12-17 |
Legacy Summary#
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FDA Review#
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