Device Classification Name |
Marker, Radiographic, Implantable
|
510(k) Number |
K152070 |
Device Name |
BioZorb LP Marker |
Applicant |
FOCAL THERAPEUTICS |
4370 Alpine Rd. #101 |
Portola Valley,
CA
94028
|
|
Applicant Contact |
George Hermann |
Correspondent |
FOCAL THERAPEUTICS |
4370 Alpine Rd. #101 |
Portola Valley,
CA
94028
|
|
Correspondent Contact |
George Hermann |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 07/27/2015 |
Decision Date | 08/26/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|