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 |