510(k) K242732
- Device
- Tristel OPH
- Applicant
- Tristel Solutions , Ltd.
- 510(k) number
- K242732
- Product code
- QWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-09
- Date received
- 2024-09-10
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Julija Shabanova
- Address
- Unit 1b, Lynx Business Park, Fordham Rd. Snailwell Cambridgeshire GB CB8 7NY CB8 7NY
FDA Registration Numbers#
- 3006892175
- 2212018
Source Documents#
Other 510(k) Records For Product Code QWS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN220041 | Tristel Duo ULT | Tristel Solutions Limited | 2023-06-02 |