The following data is part of a premarket notification filed by Focal Therapeutics with the FDA for Biozorb Lp Marker.
| Device ID | K152070 |
| 510k Number | K152070 |
| Device Name: | BioZorb LP 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-27 |
| Decision Date | 2015-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045514041 | K152070 | 000 |
| 15420045514034 | K152070 | 000 |
| 15420045514027 | K152070 | 000 |