Device Classification Name |
Endoscopic Cytology Brush
|
510(k) Number |
K913248 |
Device Name |
CYTOLOGY BRUSH |
Applicant |
ANNEX MEDICAL, INC. |
7887 FULLER RD. #109 |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
STUART J LIND |
Correspondent |
ANNEX MEDICAL, INC. |
7887 FULLER RD. #109 |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
STUART J LIND |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/22/1991 |
Decision Date | 09/30/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|