The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Challenge Packs - Version 2.
| Device ID | K073683 |
| 510k Number | K073683 |
| Device Name: | VERIFY CHALLENGE PACKS - VERSION 2 |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | John Scoville |
| Correspondent | John Scoville STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-28 |
| Decision Date | 2008-01-25 |
| Summary: | summary |