The following data is part of a premarket notification filed by Focal Therapeutics with the FDA for Tissue Marker.
| Device ID | K113202 |
| 510k Number | K113202 |
| Device Name: | TISSUE MARKER |
| Classification | Marker, Radiographic, Implantable |
| Applicant | FOCAL THERAPEUTICS 4370 ALPINE RD. #101 Portola Valley, CA 94028 |
| Contact | George Hermann |
| Correspondent | George Hermann FOCAL THERAPEUTICS 4370 ALPINE RD. #101 Portola Valley, CA 94028 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-31 |
| Decision Date | 2012-02-28 |
| Summary: | summary |