510(k) K180553
- Device
- VERIFY Spore Test Strip For S40 Sterilant
- Applicant
- Steris Corporation
- 510(k) number
- K180553
- Product code
- OVY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-05-29
- Date received
- 2018-03-01
- Regulation
- 880.6887
- Classification name
- Liquid Chemical Processing System
- 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
- Marcia L. Benedict
- 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 |
|---|---|---|---|
| K233682 | VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE | STERIS Corporation | 2023-12-15 |
| K231746 | VERIFY Spore Test Strip for S40 Sterilant Concentrate | STERIS Corporation | 2023-09-11 |
| DEN110002 | SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT | STERIS Corporation | 2012-03-30 |
Legacy Summary#
summary
FDA Review#
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