The following data is part of a premarket notification filed by Genicon, Lc with the FDA for Genicon Trocar.
| Device ID | K982472 |
| 510k Number | K982472 |
| Device Name: | GENICON TROCAR |
| Classification | Cannula, Surgical, General & Plastic Surgery |
| Applicant | GENICON, LC 573 WATERSCAPE WAY Orlando, FL 32828 |
| Contact | Gary W Haberland |
| Correspondent | Gary W Haberland GENICON, LC 573 WATERSCAPE WAY Orlando, FL 32828 |
| Product Code | GEA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-15 |
| Decision Date | 1999-02-04 |
| Summary: | summary |