The following data is part of a premarket notification filed by Genicon, Inc with the FDA for Simplystrong, Simplyezee.
| Device ID | K181791 |
| 510k Number | K181791 |
| Device Name: | SIMPLYSTRONG, SIMPLYEZEE |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-05 |
| Decision Date | 2018-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00877972007395 | K181791 | 000 |
| 00877972007371 | K181791 | 000 |
| 00877972007241 | K181791 | 000 |