Device Classification Name |
biopsy needle
|
510(k) Number |
K890327 |
Device Name |
BIOPSY NEEDLE GUIDE ATTACHMENT |
Applicant |
ELSCINT, INC. |
751 EXPRESSWAY DR. |
ITASCA,
IL
60143
|
|
Applicant Contact |
ROBERT E KENNEY |
Correspondent |
ELSCINT, INC. |
751 EXPRESSWAY DR. |
ITASCA,
IL
60143
|
|
Correspondent Contact |
ROBERT E KENNEY |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 01/23/1989 |
Decision Date | 03/08/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|