The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Modular Cassette.
| Device ID | K191522 |
| 510k Number | K191522 |
| Device Name: | Straumann Modular Cassette |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Institut Straumann AG Peter Merian-Weg 12 Basel, CH 4002 |
| Contact | Jenni Vescovo |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Road Andover, MA 01801 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-10 |
| Decision Date | 2019-12-03 |