The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Geistlich Fibro-gide.
| Device ID | K171050 |
| 510k Number | K171050 |
| Device Name: | Geistlich Fibro-Gide |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | Geistlich Pharma AG Bahnhofstrasse 40 Wolhusen, CH 6110 |
| Contact | Marco Steiner |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-07 |
| Decision Date | 2017-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07610221011612 | K171050 | 000 |
| 07610221011605 | K171050 | 000 |
| 07610221015498 | K171050 | 000 |
| 07610221015481 | K171050 | 000 |