The following data is part of a premarket notification filed by Covidien with the FDA for Signia Sterilization Tray.
| Device ID | K161347 |
| 510k Number | K161347 |
| Device Name: | Signia Sterilization Tray |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | COVIDIEN 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Katherine Y. Choi |
| Correspondent | Katherine Y. Choi COVIDIEN 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-16 |
| Decision Date | 2016-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521543898 | K161347 | 000 |