The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Geistlich Wound Matrix Plus.
Device ID | K213607 |
510k Number | K213607 |
Device Name: | Geistlich Wound Matrix PLUS |
Classification | Dressing, Wound, Collagen |
Applicant | Geistlich Pharma AG Bahnhofstrasse 40 Wolhusen, CH 6110 |
Contact | Erik Wirth |
Correspondent | Stephen P Rhodes Streamline Regulatory 3502 Dundee Dr Chevy Chase, MD 20815 |
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 | 2021-11-15 |
Decision Date | 2022-04-28 |