The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Geistlich Wound Matrix.
| Device ID | K171842 |
| 510k Number | K171842 |
| Device Name: | Geistlich Wound Matrix |
| Classification | Dressing, Wound, Collagen |
| Applicant | Geistlich Pharma AG Bahnhofstrasse 40 Wolhusen, CH Ch-6110 |
| Contact | Jan Van Der Ploeg |
| Correspondent | Stephen P. Rhodes Biologics Consulting Group, Inc 400 N. Washington St. Suite 100 Alexandria, VA 22314 |
| 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 | 2017-06-20 |
| Decision Date | 2017-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07610221012626 | K171842 | 000 |
| 07610221012619 | K171842 | 000 |
| 07610221012602 | K171842 | 000 |