The following data is part of a premarket notification filed by Steris Corporation with the FDA for Sterilization Tray.
| Device ID | K160912 |
| 510k Number | K160912 |
| Device Name: | Sterilization Tray |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| 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 | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-01 |
| Decision Date | 2016-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995003029 | K160912 | 000 |
| 00724995203931 | K160912 | 000 |
| 00724995204112 | K160912 | 000 |
| 00724995204105 | K160912 | 000 |
| 00724995204099 | K160912 | 000 |
| 00724995204044 | K160912 | 000 |
| 00724995204075 | K160912 | 000 |
| 00724995206970 | K160912 | 000 |
| 10724995002883 | K160912 | 000 |
| 00724995204082 | K160912 | 000 |
| 00724995204204 | K160912 | 000 |
| 00724995204051 | K160912 | 000 |
| 10724995002852 | K160912 | 000 |
| 00724995204068 | K160912 | 000 |
| 10724995002920 | K160912 | 000 |
| 10724995002876 | K160912 | 000 |
| 00724995204006 | K160912 | 000 |
| 00724995203979 | K160912 | 000 |
| 00724995203986 | K160912 | 000 |
| 10724995204034 | K160912 | 000 |
| 00724995003012 | K160912 | 000 |
| 00724995003005 | K160912 | 000 |
| 00724995002992 | K160912 | 000 |
| 00724995002985 | K160912 | 000 |
| 00724995002978 | K160912 | 000 |
| 00724995002961 | K160912 | 000 |
| 00724995002954 | K160912 | 000 |
| 00724995002947 | K160912 | 000 |
| 00724995002824 | K160912 | 000 |
| 00724995002817 | K160912 | 000 |
| 00724995002800 | K160912 | 000 |
| 00724995002794 | K160912 | 000 |
| 00724995002787 | K160912 | 000 |
| 00724995002770 | K160912 | 000 |
| 00724995002763 | K160912 | 000 |
| 00724995002756 | K160912 | 000 |
| 00724995002749 | K160912 | 000 |
| 00724995203948 | K160912 | 000 |