The following data is part of a premarket notification filed by Agency For Medical Innovations Gmbh with the FDA for Wi-3 Hal-rar System.
| Device ID | K150718 |
| 510k Number | K150718 |
| Device Name: | Wi-3 HAL-RAR System |
| Classification | Ligator, Hemorrhoidal |
| Applicant | AGENCY FOR MEDICAL INNOVATIONS GMBH IM LETTEN 1 Feldkirch, Vorarlberg, AT 6800 |
| Contact | Stefanie Hoellger |
| Correspondent | Allison C Komiyama AcKnowledge Regulatory Strategies 2834 Hawthorn St. San Diego, CA 92104 |
| Product Code | FHN |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-19 |
| Decision Date | 2015-06-12 |
| Summary: | summary |