510(k) K052830
K052830 is an FDA 510(k) premarket notification submitted by Artimplant AB for the device "SPORTMESH". The FDA issued a decision of Substantially Equivalent on January 19, 2006. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Artimplant AB has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 2006
- Date Received
- October 5, 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