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 |