Device Classification Name |
Gastrointestinal Tubes With Enteral Specific Connectors
|
510(k) Number |
K150286 |
Device Name |
Medline Enteral Feeding Sets |
Applicant |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDLELEIN,
IL
60060
|
|
Applicant Contact |
Stephanie Blair |
Correspondent |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDLELEIN,
IL
60060
|
|
Correspondent Contact |
Stephanie Blair |
Regulation Number | 876.5980 |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/05/2015 |
Decision Date | 04/27/2015 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|