The following data is part of a premarket notification filed by Dannik Llc with the FDA for Disposable Monopolar Laparoscopic Tips And Reusable Handles.
| Device ID | K211019 |
| 510k Number | K211019 |
| Device Name: | Disposable Monopolar Laparoscopic Tips And Reusable Handles |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Dannik LLC 941 W. Morse Blvd Suite 100 Winter Park, FL 32789 |
| Contact | Olga Haberland |
| Correspondent | Olga Haberland Dannik LLC 941 W. Morse Blvd Suite 100 Winter Park, FL 32789 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-05 |
| Decision Date | 2021-10-28 |