The following data is part of a premarket notification filed by Biogennix, Llc. with the FDA for Agilon Moldable.
| Device ID | K193168 |
| 510k Number | K193168 |
| Device Name: | Agilon Moldable |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Biogennix, LLC. 1641 McGaw Ave Irvine, CA 92614 |
| Contact | Timothy Bumbalough |
| Correspondent | Elaine Duncan Paladin Medical, Inc PO Box 560 Stillwater, MN 55082 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-15 |
| Decision Date | 2020-02-13 |