The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Vh2o2 Indicator Tape.
| Device ID | K160485 |
| 510k Number | K160485 |
| Device Name: | VERIFY VH2O2 Indicator Tape |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERIS CORPORATION 5960 HEISLEY ROAD Mentor, OH 44060 |
| Contact | Anthony Piotrkowski |
| Correspondent | Anthony Piotrkowski STERIS CORPORATION 5960 HEISLEY ROAD Mentor, OH 44060 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-22 |
| Decision Date | 2016-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995002534 | K160485 | 000 |
| 10724995172593 | K160485 | 000 |