The following data is part of a premarket notification filed by Viscus Biologics, Llc with the FDA for Radiopaque Tissue Marker.
| Device ID | K170026 |
| 510k Number | K170026 |
| Device Name: | Radiopaque Tissue Marker |
| Classification | Marker, Radiographic, Implantable |
| Applicant | Viscus Biologics, LLC 10000 Cedar Ave Cleveland, OH 44106 |
| Contact | Leslie Rebecca Clark |
| Correspondent | Leslie Rebecca Clark Viscus Biologics, LLC 10000 Cedar Ave Cleveland, OH 44106 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-03 |
| Decision Date | 2017-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850016008008 | K170026 | 000 |