The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Straumann Surgical Cassettes.
| Device ID | K203753 |
| 510k Number | K203753 |
| Device Name: | Straumann Surgical Cassettes |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 |
| Contact | Chanrasmey White |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Rd Andover, MA 01810 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-23 |
| Decision Date | 2021-07-29 |