The following data is part of a premarket notification filed by Focal Therapeutics with the FDA for Biozorb Marker Gold / Lp Marker Gold.
| Device ID | K171467 |
| 510k Number | K171467 |
| Device Name: | BioZorb Marker GOLD / LP Marker GOLD |
| Classification | Accelerator, Linear, Medical |
| Applicant | Focal Therapeutics 1010 Stewart Drive Sunnyvale, CA 94085 |
| Contact | George Hermann |
| Correspondent | George Hermann Focal Therapeutics 1010 Stewart Drive Sunnyvale, CA 94085 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-18 |
| Decision Date | 2017-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851766006177 | K171467 | 000 |
| 00851766006160 | K171467 | 000 |
| 00851766006153 | K171467 | 000 |
| 00851766006146 | K171467 | 000 |
| 00851766006139 | K171467 | 000 |
| 00851766006122 | K171467 | 000 |
| 00851766006115 | K171467 | 000 |