510(k) K233682
- Device
- VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
- Applicant
- STERIS Corporation
- 510(k) number
- K233682
- Product code
- OVY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-15
- Date received
- 2023-11-16
- Regulation
- 880.6887
- Classification name
- Liquid Chemical Processing System
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gregory Land
- Address
- 5960 Heisley Rd. Mentor OH US 44060 44060
FDA Registration Numbers#
- 3004080920
Source Documents#
Other 510(k) Records For Product Code OVY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231746 | VERIFY Spore Test Strip for S40 Sterilant Concentrate | STERIS Corporation | 2023-09-11 |
| K180553 | VERIFY Spore Test Strip for S40 Sterilant | STERIS Corporation | 2018-05-29 |
| DEN110002 | SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT | STERIS Corporation | 2012-03-30 |