The following data is part of a premarket notification filed by Scion Medical Technologies Llc with the FDA for Beacon Tissue Marker.
| Device ID | K130763 |
| 510k Number | K130763 |
| Device Name: | BEACON TISSUE MARKER |
| Classification | Marker, Radiographic, Implantable |
| Applicant | SCION MEDICAL TECHNOLOGIES LLC 23879 BLUE SPRUCE RD Sauk Centre, MN 56378 |
| Contact | Joseph Ostendorf |
| Correspondent | Joseph Ostendorf SCION MEDICAL TECHNOLOGIES LLC 23879 BLUE SPRUCE RD Sauk Centre, MN 56378 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-20 |
| Decision Date | 2013-05-08 |
| Summary: | summary |