The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify 270fp Challenge Pack.
| Device ID | K103053 |
| 510k Number | K103053 |
| Device Name: | VERIFY 270FP CHALLENGE PACK |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Robert Sullivan |
| Correspondent | Robert 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 | 2010-10-15 |
| Decision Date | 2011-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995091146 | K103053 | 000 |
| 10724995218567 | K103053 | 000 |