The following data is part of a premarket notification filed by Focal Therapeutics with the FDA for Biozorb Marker.
Device ID | K143484 |
510k Number | K143484 |
Device Name: | BioZorb 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 | 2014-12-08 |
Decision Date | 2015-06-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15420045514065 | K143484 | 000 |
15420045514058 | K143484 | 000 |
15420045514010 | K143484 | 000 |
15420045514003 | K143484 | 000 |
15420045513990 | K143484 | 000 |
15420045513983 | K143484 | 000 |