The following data is part of a premarket notification filed by Elute, Inc. with the FDA for Ep Granules™ Bvf.
| Device ID | K180853 |
| 510k Number | K180853 |
| Device Name: | EP Granules™ BVF |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Elute, Inc. 417 Wakara Way Suite 3510 Salt Lake City, UT 84108 |
| Contact | Kirk Andriano |
| Correspondent | Ashok Khandkar Elute, Inc. 417 Wakara Way Suite 3510 Salt Lake City, UT 84108 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-02 |
| Decision Date | 2018-08-06 |
| Summary: | summary |