The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify V-pro Chemical Indicator, Version 1a: Verify V-pro Chemical Indicator; Version 2a: Adhesive Label.
| Device ID | K091174 |
| 510k Number | K091174 |
| Device Name: | VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR; VERSION 2A: ADHESIVE LABEL |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Robert F Sullivan |
| Correspondent | Robert F Sullivan STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-22 |
| Decision Date | 2009-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995091115 | K091174 | 000 |
| 10724995091108 | K091174 | 000 |