Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K191387 |
Device Name |
ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube |
Applicant |
Envizion Medical Ltd. |
7 Haarad St. |
Tel Aviv,
IL
6971060
|
|
Applicant Contact |
Doron Besser |
Correspondent |
Shriner & Associates |
429 Whitepine Creek Road |
Trout Creek,
MT
59872
|
|
Correspondent Contact |
Clay Anselmo |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 05/24/2019 |
Decision Date | 06/14/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|