The following data is part of a premarket notification filed by Karl Storz Endoscopy America Inc with the FDA for Karl Storz Radel Sterilization Trays.
| Device ID | K203572 |
| 510k Number | K203572 |
| Device Name: | Karl Storz Radel Sterilization Trays |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Karl Storz Endoscopy America Inc 2151 E Grand Ave El Segundo, CA 90245 -5017 |
| Contact | Leigh Spotten |
| Correspondent | David Furr Toscano Consulting Group Inc. 8708 Capeheart 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 | 2020-12-07 |
| Decision Date | 2021-05-07 |