The following data is part of a premarket notification filed by Dannik with the FDA for Dannik Specimen Retrieval System With Deployment Mechanism, Dannik Specimen Retrieval System (bag Only).
| Device ID | K200053 |
| 510k Number | K200053 |
| Device Name: | DANNIK Specimen Retrieval System With Deployment Mechanism, DANNIK Specimen Retrieval System (Bag Only) |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-10 |
| Decision Date | 2020-04-21 |