The following data is part of a premarket notification filed by Covidien, Formerly Valleylab, A Division Of Tyco H with the FDA for Sonicision Sterilization Tray.
| Device ID | K131170 |
| 510k Number | K131170 |
| Device Name: | SONICISION STERILIZATION TRAY |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H 5920 Longbow Dr Boulder, CO 80301 |
| Contact | David Horton |
| Correspondent | David Horton COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H 5920 Longbow Dr 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 | 2013-04-24 |
| Decision Date | 2013-08-28 |
| Summary: | summary |