The following data is part of a premarket notification filed by Freudenberg Technology Innovation Se & Co. Kg with the FDA for Scaffolene Cl100 Bioresorbable Collagen Matrix.
| Device ID | K192346 |
| 510k Number | K192346 |
| Device Name: | Scaffolene CL100 Bioresorbable Collagen Matrix |
| Classification | Dressing, Wound, Collagen |
| Applicant | Freudenberg Technology Innovation SE & Co. KG Hoehnerweg 2-4 Weinheim, DE 69469 |
| Contact | Denis Reibel |
| Correspondent | Sugato De Parexel International 4600 East-West Highway, Suite 350 Bethesda, MD 20814 |
| 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 | 2019-08-29 |
| Decision Date | 2020-02-28 |