The following data is part of a premarket notification filed by Gabriel Medical, Inc. with the FDA for Infra Vision Imaging System.
| Device ID | K945297 |
| 510k Number | K945297 |
| Device Name: | INFRA VISION IMAGING SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GABRIEL MEDICAL, INC. 2014 WEST PINHOOK RD., #604 Lafayette, LA 70508 |
| Contact | Mary M Mcnamara |
| Correspondent | Mary M Mcnamara GABRIEL MEDICAL, INC. 2014 WEST PINHOOK RD., #604 Lafayette, LA 70508 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-31 |
| Decision Date | 1994-12-20 |