The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Restorelle Polypropylene Mesh; Restorelle Polypropylene Mesh.
| Device ID | K103568 |
| 510k Number | K103568 |
| Device Name: | RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Contact | Janell A Colley |
| Correspondent | Janell A Colley COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-06 |
| Decision Date | 2010-12-22 |
| Summary: | summary |