The following data is part of a premarket notification filed by Storz Medical Ag with the FDA for Storz Medical Duolith Sd1 T-top & Tower System With C-actor Sepia Handpiece.
| Device ID | K202112 |
| 510k Number | K202112 |
| Device Name: | Storz Medical Duolith SD1 T-Top & Tower System With C-Actor Sepia Handpiece |
| Classification | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers |
| Applicant | Storz Medical AG Lohstampfestrasse 8 Tagerwilen, CH Ch-8274 |
| Contact | Pavel Novak |
| Correspondent | Michael Dayton Biomed Research, Inc. 3959 Van Dyke Road, Suite 245 Lutz, FL 33558 |
| Product Code | PZL |
| CFR Regulation Number | 878.4685 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-30 |
| Decision Date | 2021-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630039101398 | K202112 | 000 |