510(k) K191545
K191545 is an FDA 510(k) premarket notification submitted by Exogenesis Corporation for the device "Exogenesis Hernia Mesh". The FDA issued a decision of Substantially Equivalent on Sep 26, 2019. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 26, 2019
- Date Received
- Jun 11, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Polymeric
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
- 510(k)