510(k) K021056
K021056 is an FDA 510(k) premarket notification submitted by Tissue Science Laboratories, Plc for the device "PERMACOL". The FDA issued a decision of Substantially Equivalent on October 31, 2002. The device falls under product code FTM (Mesh, Surgical), 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
- October 31, 2002
- Date Received
- April 1, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type