The following data is part of a premarket notification filed by Scion Medical Technologies, Llc with the FDA for Star Tissue Marker.
| Device ID | K170905 |
| 510k Number | K170905 |
| Device Name: | Star Tissue Marker |
| Classification | Marker, Radiographic, Implantable |
| Applicant | Scion Medical Technologies, LLC 4613 West Chester Pike Newtown Square, PA 19073 |
| Contact | Louis Li |
| Correspondent | Louis Li Scion Medical Technologies, LLC 4613 West Chester Pike Newtown Square, PA 19073 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-28 |
| Decision Date | 2017-04-27 |
| Summary: | summary |