Device Classification Name |
saline, vascular access flush
|
510(k) Number |
K191378 |
Device Name |
0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe |
Applicant |
Medline Industries, Inc. |
Three Lake Drive |
Northfield,
IL
60093
|
|
Applicant Contact |
Stephanie Augsburg |
Correspondent |
Medline Industries, Inc. |
Three Lake Drive |
Northfield,
IL
60093
|
|
Correspondent Contact |
Stephanie Augsburg |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 05/23/2019 |
Decision Date | 09/15/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|