The following data is part of a premarket notification filed by View Point Medical, Inc. with the FDA for Signalmark Breast Marker.
| Device ID | K190689 |
| 510k Number | K190689 |
| Device Name: | SignalMark Breast Marker |
| Classification | Marker, Radiographic, Implantable |
| Applicant | View Point Medical, Inc. 5621 Palmer Way, Suite F Carlsbad, CA 92010 |
| Contact | Thomas Kane |
| Correspondent | Michelle Rubin-onur AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave Suite B-257 San Diego, CA 92110 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-18 |
| Decision Date | 2019-08-14 |