The following data is part of a premarket notification filed by Tissue Science Laboratories, Plc with the FDA for Permacol Surgical Implant.
| Device ID | K043366 |
| 510k Number | K043366 |
| Device Name: | PERMACOL SURGICAL IMPLANT |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | TISSUE SCIENCE LABORATORIES, PLC 1141 CLARK STREET, SUITE D Covington, GA 30014 |
| Contact | Victoria Taylor |
| Correspondent | Victoria Taylor TISSUE SCIENCE LABORATORIES, PLC 1141 CLARK STREET, SUITE D Covington, GA 30014 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-08 |
| Decision Date | 2004-12-17 |
| Summary: | summary |