The following data is part of a premarket notification filed by Tissue Science Laboratories, Plc with the FDA for Permacol Surgical Implant T-piece, Permacol Surgical Implant Rectocele-piece, Models 5928-150, 5645-150.
| Device ID | K050355 |
| 510k Number | K050355 |
| Device Name: | PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 |
| Classification | Mesh, Surgical, Non-synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| 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 | PAI |
| CFR Regulation Number | 884.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-14 |
| Decision Date | 2005-03-09 |
| Summary: | summary |