The following data is part of a premarket notification filed by Viscus Biologics, Llc with the FDA for Fibermarx Radiopaque Tissue Marker.
| Device ID | K190155 |
| 510k Number | K190155 |
| Device Name: | FibermarX Radiopaque Tissue Marker |
| Classification | Accelerator, Linear, Medical |
| Applicant | Viscus Biologics, LLC 10000 Cedar Avenue Cleveland, OH 44106 |
| Contact | Justin Baker |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-01-30 |
| Decision Date | 2019-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850016008046 | K190155 | 000 |
| 00850016008183 | K190155 | 000 |