The following data is part of a premarket notification filed by Karl Storz Endoscopyamerica Inc with the FDA for Karl Storz Udel Sterilization Trays.
| Device ID | K201945 |
| 510k Number | K201945 |
| Device Name: | KARL STORZ UDEL Sterilization Trays |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Karl Storz EndoscopyAmerica Inc 2151 E Grand Ave El Segundo, CA 90245 -5017 |
| Contact | Leigh Spotten |
| Correspondent | David Furr Toscano Consulting 8708 Capehart Cove Austin, TX 78733 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-13 |
| Decision Date | 2021-02-25 |