Device Classification Name |
instrument, biopsy
|
510(k) Number |
K042290 |
Device Name |
VACUUM ASSISTED CORE BIOPSY DEVICE |
Applicant |
SUROS SURGICAL SYSTEMS, INC. |
9502 ANGOLA COURT SUITE 3 |
INDIANAPOLIS,
IN
46268
|
|
Applicant Contact |
JOSEPH MARK |
Correspondent |
SUROS SURGICAL SYSTEMS, INC. |
9502 ANGOLA COURT SUITE 3 |
INDIANAPOLIS,
IN
46268
|
|
Correspondent Contact |
JOSEPH MARK |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 08/24/2004 |
Decision Date | 10/06/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|