The following data is part of a premarket notification filed by Focal Therapeutics with the FDA for Biozorb Sp Marker.
| Device ID | K192371 |
| 510k Number | K192371 |
| Device Name: | BioZorb SP Marker |
| Classification | Marker, Radiographic, Implantable |
| Applicant | Focal Therapeutics 1010 Stewart Drive Sunnyvale, CA 94085 |
| Contact | Dhaval Saraiya |
| Correspondent | Dhaval Saraiya Focal Therapeutics 1010 Stewart Drive Sunnyvale, CA 94085 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-30 |
| Decision Date | 2019-09-26 |
| Summary: | summary |