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 |