The following data is part of a premarket notification filed by Scion Medical Technologies, Llc with the FDA for Beacon Tissue Marker (se).
| Device ID | K153189 |
| 510k Number | K153189 |
| Device Name: | Beacon Tissue Marker (SE) |
| 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 | 2015-11-03 |
| Decision Date | 2015-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30866479000115 | K153189 | 000 |