The following data is part of a premarket notification filed by Livac Pty Ltd with the FDA for Livac Retractor System.
| Device ID | K162445 |
| 510k Number | K162445 |
| Device Name: | LiVac Retractor System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Livac Pty Ltd 8 Melaleuca Court Warrnambool, AU 3280 |
| Contact | Anabela Correia |
| Correspondent | Stuart R. Goldman Emergo Global 2500 Bee Cave, Bldg 1, Suite 300 Austin, TX 78746 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-31 |
| Decision Date | 2016-10-20 |
| Summary: | summary |