Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K160509 |
Device Name |
Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube |
Applicant |
COOK INCORPORATED |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Applicant Contact |
Erum B. Nasir |
Correspondent |
COOK INCORPORATED |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Correspondent Contact |
Erum B. Nasir |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 02/24/2016 |
Decision Date | 05/18/2017 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|