The following data is part of a premarket notification filed by Dannik with the FDA for Dannik Disposable Monopolar Laparoscopic Instrument.
| Device ID | K193019 |
| 510k Number | K193019 |
| Device Name: | DANNIK Disposable Monopolar Laparoscopic Instrument |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Dannik 941 W Morse Blvd. Suite 100 Winter Park, FL 32789 |
| Contact | Olga Haberlad |
| Correspondent | Olga Haberland Dannik 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 | 2019-10-29 |
| Decision Date | 2020-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850013527786 | K193019 | 000 |
| 00850013527410 | K193019 | 000 |
| 00850013527441 | K193019 | 000 |
| 00850013527809 | K193019 | 000 |
| 00850013527038 | K193019 | 000 |
| 00850013527045 | K193019 | 000 |
| 00850013527052 | K193019 | 000 |
| 00850013527069 | K193019 | 000 |
| 00850013527342 | K193019 | 000 |
| 00850013527359 | K193019 | 000 |
| 00850013527397 | K193019 | 000 |