Device Classification Name |
Biopsy Needle
|
510(k) Number |
K941563 |
Device Name |
THE BIOPSY TOOL |
Applicant |
CITATION MEDICAL CORP. |
230 EDISON WAY |
RENO,
NV
89502
|
|
Applicant Contact |
EDWARD F WADDELL |
Correspondent |
CITATION MEDICAL CORP. |
230 EDISON WAY |
RENO,
NV
89502
|
|
Correspondent Contact |
EDWARD F WADDELL |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 04/01/1994 |
Decision Date | 09/26/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|