510(k) K200926
K200926 is an FDA 510(k) premarket notification submitted by Tissue Regeneration Technologies, LLC for the device "OrthoGold 100". The FDA issued a decision of Substantially Equivalent on August 28, 2020. The device falls under product code PZL (Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers), a Class II device regulated under 21 CFR 878.4685. Tissue Regeneration Technologies, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2020
- Date Received
- April 7, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
- Device Class
- Class II
- Regulation Number
- 878.4685
- Review Panel
- SU
- Submission Type
Treatment of diabetic foot ulcers