Device Classification Name |
instrument, biopsy
|
510(k) Number |
K180450 |
Device Name |
Corvocet Biopsy System |
Applicant |
Merit Medical Systems, Inc. |
1600 W Merit Parkway |
South Jordan,
UT
84095
|
|
Applicant Contact |
Angela Brady |
Correspondent |
Merit Medical Systems, Inc. |
1600 W Merit Parkway |
South Jordan,
UT
84095
|
|
Correspondent Contact |
Angela Brady |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 02/20/2018 |
Decision Date | 03/12/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|