The following data is part of a premarket notification filed by Covidien with the FDA for Sonicision Reusable Sterilization Tray.
| Device ID | K180915 |
| 510k Number | K180915 |
| Device Name: | Sonicision Reusable Sterilization Tray |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Covidien 5920 Longbow Drive Boulder, CO 80301 |
| Contact | Candice Bautista-biddle |
| Correspondent | Candice Bautista-biddle Covidien 5920 Longbow Drive Boulder, CO 80301 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-09 |
| Decision Date | 2018-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521592919 | K180915 | 000 |