The following data is part of a premarket notification filed by Sweden & Martina S.p.a. with the FDA for Sweden & Martina Surgical Tray (model Zshorty-int).
| Device ID | K182084 |
| 510k Number | K182084 |
| Device Name: | Sweden & Martina Surgical Tray (Model ZSHORTY-INT) |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Sweden & Martina S.p.A. via Veneto 10 Due Carrare, IT 35020 |
| Contact | Alessia Pezzato |
| Correspondent | Alessia Pezzato Sweden & Martina S.p.A. via Veneto 10 Due Carrare, IT 35020 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-02 |
| Decision Date | 2020-11-04 |