510(k) DEN220041
- Device
- Tristel Duo ULT
- Applicant
- Tristel Solutions Limited
- 510(k) number
- DEN220041
- Product code
- QWS
- Decision
- Unknown (DENG)
- Decision date
- 2023-06-02
- Date received
- 2022-06-29
- Regulation
- 880.6886
- Classification name
- Foam Or Gel Chemical Sterilant/High Level Disinfectant
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Julija Shabanova
- Address
- Unit 1b, Lynx Business Park, Fordham Rd. Snailwell GB CB8 7NY CB8 7NY
FDA Registration Numbers#
- 3006892175
- 2212018
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QWS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242732 | Tristel OPH | Tristel Solutions , Ltd. | 2025-05-09 |