The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Assert Steam Process Challenge Device For Gravity Cycles.
| Device ID | K170070 |
| 510k Number | K170070 |
| Device Name: | VERIFY ASSERT STEAM Process Challenge Device For Gravity Cycles |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | STERIS Corporation 5976 Heisley Rd Mentor, OH 44060 |
| Contact | Anthony Piotrkowski |
| Correspondent | Anthony Piotrkowski STERIS Corporation 5976 Heisley Rd Mentor, OH 44060 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-09 |
| Decision Date | 2017-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995153042 | K170070 | 000 |