The following data is part of a premarket notification filed by Aeon Astron Europe B.v. with the FDA for Ologen Collagen Matrix.
| Device ID | K173223 |
| 510k Number | K173223 |
| Device Name: | Ologen Collagen Matrix |
| Classification | Dressing, Wound, Collagen |
| Applicant | Aeon Astron Europe B.V. J.H. Oortweg 19 Leiden, NL 2333 Ch |
| Contact | Horng Ji Lai |
| Correspondent | Horng Ji Lai Aeon Astron Europe B.V. J.H. Oortweg 19 Leiden, NL 2333 Ch |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-03 |
| Decision Date | 2018-03-02 |
| Summary: | summary |