Device Classification Name |
Endoscopic Cytology Brush
|
510(k) Number |
K942144 |
Device Name |
URETHRA-BRUSH |
Applicant |
ROVERS DIAGNOSTIC DEVICES |
P.O. BOX 524 |
BOONTON,
NJ
07005
|
|
Applicant Contact |
JOHN G RICHARDSON |
Correspondent |
ROVERS DIAGNOSTIC DEVICES |
P.O. BOX 524 |
BOONTON,
NJ
07005
|
|
Correspondent Contact |
JOHN G RICHARDSON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 05/03/1994 |
Decision Date | 06/27/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|