The following data is part of a premarket notification filed by Kensey Nash Corporation with the FDA for Mesothelium Dental Membrane.
| Device ID | K121310 |
| 510k Number | K121310 |
| Device Name: | MESOTHELIUM DENTAL MEMBRANE |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | KENSEY NASH CORPORATION 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Contact | Lori Burns, Ms, Rac |
| Correspondent | Lori Burns, Ms, Rac KENSEY NASH CORPORATION 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-01 |
| Decision Date | 2013-07-11 |
| Summary: | summary |