The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Mesosfol Surgical Film.
| Device ID | K062558 |
| 510k Number | K062558 |
| Device Name: | MESOSFOL SURGICAL FILM |
| Classification | Mesh, Surgical |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Erika Martin |
| Correspondent | Erika Martin BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-30 |
| Decision Date | 2007-06-20 |
| Summary: | summary |