Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K163002 |
Device Name |
Kangaroo Feeding Tube with IRIS Technology |
Applicant |
Covidien (dba Medtronic) |
15 Hampshire St |
Mansfield,
MA
02048
|
|
Applicant Contact |
Alexis Erazo |
Correspondent |
Covidien (dba Medtronic) |
15 Hampshire St |
Mansfield,
MA
02048
|
|
Correspondent Contact |
Alexis Erazo |
Regulation Number | 876.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/28/2016 |
Decision Date | 05/16/2017 |
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
|
|
|