The following data is part of a premarket notification filed by Viewpoint Medical, Inc. with the FDA for Signalmark Lung Biopsy Site Marker.
| Device ID | K180175 |
| 510k Number | K180175 |
| Device Name: | SignalMark Lung Biopsy Site Marker |
| Classification | Staple, Implantable |
| Applicant | ViewPoint Medical, Inc. 1235 Puerta Del Sol #600 San Clemente, CA 92673 |
| Contact | Thomas Kane |
| Correspondent | Thomas Kane ViewPoint Medical, Inc. 1235 Puerta Del Sol #600 San Clemente, CA 92673 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-22 |
| Decision Date | 2018-12-07 |
| Summary: | summary |