Device Classification Name |
Cystoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K142194 |
Device Name |
CytoSure Urinary Access System |
Applicant |
Emmy Medical |
18 Hillside Drive |
Holliston,
ME
01746
|
|
Applicant Contact |
Christine G Santagate |
Correspondent |
R&Q Solutions |
15 Standish Rd |
Norfolk,
MA
02056
|
|
Correspondent Contact |
Christine Santagate |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/11/2014 |
Decision Date | 12/19/2014 |
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
|
|
|