The following data is part of a premarket notification filed by Genicon, Lc with the FDA for Reusable Cannula.
| Device ID | K002542 |
| 510k Number | K002542 |
| Device Name: | REUSABLE CANNULA |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GENICON, LC 573 WATERSCAPE WAY Orlando, FL 32828 |
| Contact | Gary Haberland |
| Correspondent | Gary Haberland GENICON, LC 573 WATERSCAPE WAY Orlando, FL 32828 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-16 |
| Decision Date | 2000-10-23 |