Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K162826 |
Device Name |
Encore Neutral |
Applicant |
RyMed Technologies, LLC |
6000 W. William Cannon Drive B300 |
Austin,
TX
78749
|
|
Applicant Contact |
Anna McCutchen |
Correspondent |
RyMed Technologies, LLC |
6000 W. William Cannon Drive B300 |
Austin,
TX
78749
|
|
Correspondent Contact |
Anna McCutchen |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 10/07/2016 |
Decision Date | 06/15/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|