Device Classification Name |
gastrointestinal tubes with enteral specific connectors
|
510(k) Number |
K213258 |
Device Name |
Nasogastric Feeding Tubes - ENFit Port - PVC |
Applicant |
Cair Lgl |
Parc Tertiaire De Bois Dieu, 1 Allee Des Chevreuils |
Lissieu,
FR
69380
|
|
Applicant Contact |
Irving L. Wiesen |
Correspondent |
Vesco Medical |
1039 Kingsmill Parkway |
Columbus,
OH
43229
|
|
Correspondent Contact |
Glenn Brunner |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 09/30/2021 |
Decision Date | 06/09/2022 |
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
|
|
|