The following data is part of a premarket notification filed by Organogenesis, Inc. with the FDA for Fortagen Oral Membrane.
| Device ID | K071555 |
| 510k Number | K071555 |
| Device Name: | FORTAGEN ORAL MEMBRANE |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | ORGANOGENESIS, INC. 150 DAN RD. Canton, MA 02021 |
| Contact | Patrick R Bilbo |
| Correspondent | Patrick R Bilbo ORGANOGENESIS, INC. 150 DAN RD. Canton, MA 02021 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-07 |
| Decision Date | 2007-08-30 |
| Summary: | summary |