510(k) K053066
K053066 is an FDA 510(k) premarket notification submitted by Genzyme Corporation for the device "SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH". The FDA issued a decision of Substantially Equivalent on December 19, 2005. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Genzyme Corporation has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2005
- Date Received
- November 1, 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