510(k) K082748
K082748 is an FDA 510(k) premarket notification submitted by Atrium Medical Corp. for the device "ATRIUM PROLITE S MESH". The FDA issued a decision of Substantially Equivalent on January 14, 2009. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Atrium Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 2009
- Date Received
- September 19, 2008
- Clearance Type
- Special
- 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