510(k) K081327
K081327 is an FDA 510(k) premarket notification submitted by Herniamesh S.R.L. for the device "RELIMESH". The FDA issued a decision of Substantially Equivalent on Jun 19, 2008. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Herniamesh S.R.L. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 19, 2008
- Date Received
- May 12, 2008
- 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)