Device Classification Name |
gastrointestinal tubes with enteral specific connectors
|
510(k) Number |
K223683 |
Device Name |
EnteraLoc Flow |
Applicant |
Vonco Products |
10826 250th Avenue |
Trevor,
WI
53179
|
|
Applicant Contact |
Christie Marr |
Correspondent |
Vonco Products |
10826 250th Avenue |
Trevor,
WI
53179
|
|
Correspondent Contact |
Christie Marr |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 12/08/2022 |
Decision Date | 07/10/2023 |
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
|
|
|