The following data is part of a premarket notification filed by Mesynthe Ltd with the FDA for Endoform Reconstructive Template.
| Device ID | K130547 |
| 510k Number | K130547 |
| Device Name: | ENDOFORM RECONSTRUCTIVE TEMPLATE |
| Classification | Mesh, Surgical |
| Applicant | MESYNTHE LTD 11440 W. BERNARDO CT SUITE 300 San Diego, CA 92127 |
| Contact | Ronald Warren |
| Correspondent | Ronald Warren MESYNTHE LTD 11440 W. BERNARDO CT SUITE 300 San Diego, CA 92127 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-04 |
| Decision Date | 2013-05-31 |
| Summary: | summary |