Device Classification Name |
System, X-Ray, Mammographic
|
510(k) Number |
K202294 |
Device Name |
Affirm Contrast Biopsy |
Applicant |
Hologic, Inc |
36 Apple Ridge Road |
Danbury,
CT
06810
|
|
Applicant Contact |
Kate Brown |
Correspondent |
Hologic, Inc |
36 Apple Ridge Road |
Danbury,
CT
06810
|
|
Correspondent Contact |
Kate Brown |
Regulation Number | 892.1710
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/13/2020 |
Decision Date | 10/05/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|