The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Steam Indicators, Models 250f 25, 250f 30, 270f 15, 270f 3-10 And 270f 4.
| Device ID | K070461 |
| 510k Number | K070461 |
| Device Name: | VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4 |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-16 |
| Decision Date | 2007-07-17 |
| Summary: | summary |