The following data is part of a premarket notification filed by Biogennix, Llc with the FDA for Agilon Strip.
| Device ID | K193487 |
| 510k Number | K193487 |
| Device Name: | Agilon Strip |
| 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 | 2019-12-17 |
| Decision Date | 2020-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812593020392 | K193487 | 000 |
| 00812593020385 | K193487 | 000 |
| 00812593022266 | K193487 | 000 |
| 00812593022259 | K193487 | 000 |
| 00812593021672 | K193487 | 000 |
| 00812593021665 | K193487 | 000 |