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 |