The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Incubator For Assert Self Contained Biological Indicators.
| Device ID | K163587 |
| 510k Number | K163587 |
| Device Name: | VERIFY Incubator For Assert Self Contained Biological Indicators |
| Classification | Biological Sterilization Process Indicator With Recombinant-dna Plasmid |
| 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 | OWP |
| CFR Regulation Number | 880.2805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-20 |
| Decision Date | 2017-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995153052 | K163587 | 000 |
| 00724995002541 | K163587 | 000 |