The following data is part of a premarket notification filed by Kensey Nash Corporation Dba Dsm Biomedical with the FDA for Dsm Biomedical Calcium Phosphate Cement.
| Device ID | K173362 |
| 510k Number | K173362 |
| Device Name: | DSM Biomedical Calcium Phosphate Cement |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Kensey Nash Corporation Dba DSM Biomedical 735 Pennsylvania Drive Exton, PA 19431 |
| Contact | Susan Pileggi |
| Correspondent | Susan Pileggi Kensey Nash Corporation Dba DSM Biomedical 735 Pennsylvania Drive Exton, PA 19431 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-26 |
| Decision Date | 2018-04-03 |
| Summary: | summary |