510(k) K192452
K192452 is an FDA 510(k) premarket notification submitted by B. Bruan Surgical, SA for the device "Lyograft". The FDA issued a decision of Substantially Equivalent on September 3, 2020. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 2020
- Date Received
- September 9, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type