Device Classification Name |
Tube, Gastro-Enterostomy
|
510(k) Number |
K191844 |
Device Name |
Fidmi Low Profile Enteral Feeding Device |
Applicant |
Fidmi Medical Ltd |
5 Haeshel St. |
Caesarea Business Park, Caesarea,
IL
3079500
|
|
Applicant Contact |
Shahar Millis |
Correspondent |
Hogan Lovells US LLP |
1735 Market Street, Floor 23 |
Philadelphia,
PA
19103
|
|
Correspondent Contact |
Janice M. Hogan |
Regulation Number | 876.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/09/2019 |
Decision Date | 09/30/2019 |
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
|
|
|