The following data is part of a premarket notification filed by Genicon, Inc with the FDA for Genistrong.
| Device ID | K180836 |
| 510k Number | K180836 |
| Device Name: | Genistrong |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Genicon, Inc 6869 Stapoint Court Suite 114 Winter Park, FL 32792 |
| Contact | Katlyn Kachman |
| Correspondent | Katlyn Kachman Genicon, Inc 6869 Stapoint Court Suite 114 Winter Park, FL 32792 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-30 |
| Decision Date | 2018-04-18 |
| Summary: | summary |