Device Classification Name |
instrument, biopsy
|
510(k) Number |
K202012 |
Device Name |
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System |
Applicant |
Devicor Medical Products, Inc. |
300 E-Business Way, Fifth Floor |
Cincinnati,
OH
45241
|
|
Applicant Contact |
Gwendolyn P. Payne |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 07/21/2020 |
Decision Date | 08/18/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|