The following data is part of a premarket notification filed by Aeon Astron Europe B.v. with the FDA for Aongen Collagen Matrix.
| Device ID | K080868 |
| 510k Number | K080868 |
| Device Name: | AONGEN COLLAGEN MATRIX |
| Classification | Dressing, Wound, Collagen |
| Applicant | AEON ASTRON EUROPE B.V. NIELS BOHRWEG 11-13 Leiden, NL 2333 |
| Contact | Horng J Lai |
| Correspondent | Horng J Lai AEON ASTRON EUROPE B.V. NIELS BOHRWEG 11-13 Leiden, NL 2333 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-28 |
| Decision Date | 2009-05-14 |
| Summary: | summary |