Device Classification Name |
gastrointestinal tubes with enteral specific connectors
|
510(k) Number |
K191759 |
Device Name |
Medline Quick Switch Valve with ENFit Connector |
Applicant |
Medline Industries, Inc. |
Three Lakes Drive |
Northfield,
IL
60093
|
|
Applicant Contact |
Dinah Rincones |
Correspondent |
Medline Industries, Inc. |
Three Lakes Drive |
Northfield,
IL
60093
|
|
Correspondent Contact |
Dinah Rincones |
Regulation Number | 876.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/01/2019 |
Decision Date | 12/04/2019 |
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
|
|
|