The following data is part of a premarket notification filed by Kensey Nash Corporation Dba Dsm Biomedical with the FDA for Dsm Biomedical Porcine Pericardium Dental Membrane.
| Device ID | K160474 |
| 510k Number | K160474 |
| Device Name: | DSM Biomedical Porcine Pericardium Dental Membrane |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | Kensey Nash Corporation Dba DSM Biomedical 735 Pennsylvania Drive Exton, PA 19431 |
| Contact | Brianna Schehr |
| Correspondent | Brianna Schehr Kensey Nash Corporation Dba DSM Biomedical 735 Pennsylvania Drive Exton, PA 19431 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-19 |
| Decision Date | 2016-06-07 |
| Summary: | summary |