510(k) K043366
K043366 is an FDA 510(k) premarket notification submitted by Tissue Science Laboratories, Plc for the device "PERMACOL SURGICAL IMPLANT". The FDA issued a decision of Substantially Equivalent on December 17, 2004. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Tissue Science Laboratories, Plc has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2004
- Date Received
- December 8, 2004
- 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