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 |