The following data is part of a premarket notification filed by Surgicraft Ltd. with the FDA for Surgicraft Surgical Mesh System.
| Device ID | K072370 |
| 510k Number | K072370 |
| Device Name: | SURGICRAFT SURGICAL MESH SYSTEM |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SURGICRAFT LTD. 111 HILL ROAD Douglassville, PA 19518 |
| Contact | Donald Guthner |
| Correspondent | Donald Guthner SURGICRAFT LTD. 111 HILL ROAD Douglassville, PA 19518 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-23 |
| Decision Date | 2008-07-24 |
| Summary: | summary |