The following data is part of a premarket notification filed by Dannik with the FDA for Dannik Titanium Ligation Clip.
| Device ID | K192711 |
| 510k Number | K192711 |
| Device Name: | Dannik Titanium Ligation Clip |
| Classification | Clip, Implantable |
| Applicant | Dannik 941 W Morse Blvd. Suite 100 Winter Park, FL 32789 |
| Contact | Olga Haberlad |
| Correspondent | Olga Haberlad Dannik 941 W Morse Blvd. Suite 100 Winter Park, FL 32789 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-27 |
| Decision Date | 2019-12-20 |