Device Classification Name |
instrument, biopsy
|
510(k) Number |
K152989 |
Device Name |
Mammotome revolve Dual Vacuum Assist Biopsy System |
Applicant |
DEVICOR MEDICAL PRODUCTS, INC. |
300 E-BUSINESS WAY, FIFTH FLOOR |
CINCINNATI,
OH
45241
|
|
Applicant Contact |
SHAWNA M. ROSE |
Correspondent |
DEVICOR MEDICAL PRODUCTS, INC. |
300 E-BUSINESS WAY, FIFTH FLOOR |
CINCINNATI,
OH
45241
|
|
Correspondent Contact |
SHAWNA M. ROSE |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 10/13/2015 |
Decision Date | 02/25/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|