The following data is part of a premarket notification filed by Carefusion with the FDA for Carefusion Gold Tissue Marker.
| Device ID | K141722 |
| 510k Number | K141722 |
| Device Name: | CAREFUSION GOLD TISSUE MARKER |
| Classification | Marker, Radiographic, Implantable |
| Applicant | CAREFUSION 75 NORTH FAIRWAY DRIVE Vernon Hills, IL 60061 |
| Contact | Joy Greidanus |
| Correspondent | Joy Greidanus CAREFUSION 75 NORTH FAIRWAY DRIVE Vernon Hills, IL 60061 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-25 |
| Decision Date | 2015-01-23 |
| Summary: | summary |