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 |