510(k) K053562
K053562 is an FDA 510(k) premarket notification submitted by Tissue Science Laboratories, Plc for the device "ZIMMER COLLAGEN REPAIR PATCH". The FDA issued a decision of Substantially Equivalent on June 23, 2006. 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
- June 23, 2006
- Date Received
- December 21, 2005
- 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