The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Blx Surgical Cassette.
| Device ID | K180791 |
| 510k Number | K180791 |
| Device Name: | Straumann BLX Surgical Cassette |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Institut Straumann AG Peter Merian Weg 12 Basel, CH Ch-4002 |
| Contact | Anna Vianna |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Road 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 | 2018-03-27 |
| Decision Date | 2018-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031747396 | K180791 | 000 |
| 07630031744791 | K180791 | 000 |