Device Classification Name |
Catheter, Retention Type, Balloon
|
510(k) Number |
K181346 |
Device Name |
CystoSure Plus Catheter |
Applicant |
Emmy Medical, LLC. |
18 Hillside Drive |
Holliston,
MA
01746
|
|
Applicant Contact |
Ronald Adams |
Correspondent |
R&Q Solutions, LLC. |
15 Standish Rd |
Norfolk,
MA
02056
|
|
Correspondent Contact |
Christine Santagate |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 05/21/2018 |
Decision Date | 08/06/2018 |
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
|
|
|