Device Classification Name |
gastrointestinal tubes with enteral specific connectors
|
510(k) Number |
K213356 |
Device Name |
Entuit PEG, Entuit PEGJ |
Applicant |
Wilson-Cook Medical, Inc. |
4900 Bethania Station Road |
Winston-Salem,
NC
27105
|
|
Applicant Contact |
Tiffanny A. Thomas |
Correspondent |
Wilson-Cook Medical, Inc. |
4900 Bethania Station Road |
Winston-Salem,
NC
27105
|
|
Correspondent Contact |
Tiffanny A. Thomas |
Regulation Number | 876.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/12/2021 |
Decision Date | 01/20/2022 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|