The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Geistlich Bio-gide Shape, Geistlich Bio-gide Compressed.
| Device ID | K171643 |
| 510k Number | K171643 |
| Device Name: | Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | Geistlich Pharma AG Bahnhofstrasse 40 Wolhusen, CH Ch- 6110 |
| Contact | Marco Steiner |
| Correspondent | Janice 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 | 2017-06-02 |
| Decision Date | 2017-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07610221012220 | K171643 | 000 |
| 07610221012213 | K171643 | 000 |
| 07610221012114 | K171643 | 000 |