Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K183336 |
Device Name |
Entuit PEG, Entuit PEGJ |
Applicant |
Wilson-Cook Medical, Inc |
4900 Bethania Station Road |
Winston-Salem,
NC
27105
|
|
Applicant Contact |
Tiffany A. Thomas |
Correspondent |
Wilson-Cook Medical, Inc |
4900 Bethania Station Road |
Winston-Salem,
NC
27105
|
|
Correspondent Contact |
Tiffany A. Thomas |
Regulation Number | 876.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/03/2018 |
Decision Date | 05/29/2019 |
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
|
|
|