The following data is part of a premarket notification filed by Genicon, Lc with the FDA for Shieldedtrocar/cannula System, Model 101-005-101.
| Device ID | K991382 |
| 510k Number | K991382 |
| Device Name: | SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101 |
| 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 | 1999-04-21 |
| Decision Date | 1999-07-15 |
| Summary: | summary |