Device Classification Name |
instrument, biopsy
|
510(k) Number |
K011575 |
Device Name |
22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022 |
Applicant |
IMAGYN SURGICAL |
8850 M-89 |
PO BOX 351 |
RICHLAND,
MI
49083
|
|
Applicant Contact |
JULIE POWELL |
Correspondent |
IMAGYN SURGICAL |
8850 M-89 |
PO BOX 351 |
RICHLAND,
MI
49083
|
|
Correspondent Contact |
JULIE POWELL |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 05/22/2001 |
Decision Date | 08/17/2001 |
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
|
|
|