510(k) K063154
K063154 is an FDA 510(k) premarket notification submitted by Evera Medical, Inc. for the device "FACIAL RECONSTRUCTIVE MESH (FRM)". The FDA issued a decision of Substantially Equivalent on July 10, 2007. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Evera Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2007
- Date Received
- October 16, 2006
- 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