The following data is part of a premarket notification filed by Cytophil Inc with the FDA for Cytophil Tissue Marker.
| Device ID | K072219 |
| 510k Number | K072219 |
| Device Name: | CYTOPHIL TISSUE MARKER |
| Classification | Marker, Radiographic, Implantable |
| Applicant | CYTOPHIL INC 5546 N SANTA MONICA BLVD Whitefish Bay, WI 53217 -5159 |
| Contact | Greg Johnson |
| Correspondent | Greg Johnson CYTOPHIL INC 5546 N SANTA MONICA BLVD Whitefish Bay, WI 53217 -5159 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-10 |
| Decision Date | 2008-01-18 |
| Summary: | summary |