510(k) K232924
K232924 is an FDA 510(k) premarket notification submitted by Deep Blue Medical Advances, Inc. for the device "T-Line® Hernia Mesh". The FDA issued a decision of Substantially Equivalent on October 18, 2023. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Deep Blue Medical Advances, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2023
- Date Received
- September 19, 2023
- Clearance Type
- Special
- 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