510(k) K140501
K140501 is an FDA 510(k) premarket notification submitted by C. R. Bard for the device "XENMATRIX SURGICAL GRAFT". The FDA issued a decision of Substantially Equivalent on April 28, 2014. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. C. R. Bard has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2014
- Date Received
- February 27, 2014
- Clearance Type
- Special
- 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