Device Classification Name |
biopsy needle
|
510(k) Number |
K963894 |
Device Name |
SMARTGUIDE |
Applicant |
FERGUSON MEDICAL |
3407 BAY AVE. |
CHICO,
CA
95973 -8619
|
|
Applicant Contact |
FRANK FERGUSON |
Correspondent |
FERGUSON MEDICAL |
3407 BAY AVE. |
CHICO,
CA
95973 -8619
|
|
Correspondent Contact |
FRANK FERGUSON |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 09/27/1996 |
Decision Date | 03/11/1997 |
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
|
|
|