The following data is part of a premarket notification filed by Health Beacons, Inc. with the FDA for 5cm Tag Applicator, 7cm Tag Applicator, 10 Cm Tag Applicator, 5 Cm Tag Applicator (10 Pack), 7cm Tag Applicator (10 Pack), 10cm Tag Applicator (10 Pack), Localizer Surgical Probe, Localizer Surgical Probe (5 Pack).
| Device ID | K181692 |
| 510k Number | K181692 |
| Device Name: | 5cm Tag Applicator, 7cm Tag Applicator, 10 Cm Tag Applicator, 5 Cm Tag Applicator (10 Pack), 7cm Tag Applicator (10 Pack), 10cm Tag Applicator (10 Pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 Pack) |
| Classification | Marker, Radiographic, Implantable |
| Applicant | Health Beacons, Inc. 34 Walden St., #753 Concord, MA 01742 |
| Contact | Nancy Confrey |
| Correspondent | Felicia Hosey Regulatory And Quality Solutions, LLC. 2790 Mosside Boulevard, Suite 800 Monroeville, PA 15146 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-27 |
| Decision Date | 2018-09-25 |
| Summary: | summary |