510(k) K050418
K050418 is an FDA 510(k) premarket notification submitted by Tfs Manufacturing Pty, Ltd. for the device "TISSUE FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 16, 2005. 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
- May 16, 2005
- Date Received
- Feb 18, 2005
- 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)