Device Classification Name |
catheter, urethral
|
510(k) Number |
K182511 |
Device Name |
SimplCath |
Applicant |
F&S Medical Solutions, LLC |
10221 Woodridge Lane |
Omaha,
NE
68124
|
|
Applicant Contact |
Sonia M. Rocha-Sanchez |
Correspondent |
Vision28 |
915 SW Rimrock Way STE 201 PMB 402 |
Redmond,
OR
97756
|
|
Correspondent Contact |
Tom Renner |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 09/12/2018 |
Decision Date | 03/20/2019 |
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
|
|
|