The following data is part of a premarket notification filed by Tissue Regeneration Technologies, Llc with the FDA for Orthogold 100.
| Device ID | K200926 |
| 510k Number | K200926 |
| Device Name: | OrthoGold 100 |
| Classification | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers |
| Applicant | Tissue Regeneration Technologies, LLC 251 Heritage Walk Woodstock, GA 30188 |
| Contact | John Warlick |
| Correspondent | Jennifer A. Daudelin M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 New York, NY 10018 |
| Product Code | PZL |
| CFR Regulation Number | 878.4685 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-07 |
| Decision Date | 2020-08-28 |