Device Classification Name |
Tube, Feeding
|
510(k) Number |
K121105 |
Device Name |
NUTRISAFE 2 FEEDING TUBE |
Applicant |
VYGON CORP. |
103A PARK ROAD |
MONTGOMERYVILLE,
PA
18936
|
|
Applicant Contact |
JILLIAN MIKOVICH |
Correspondent |
VYGON CORP. |
103A PARK ROAD |
MONTGOMERYVILLE,
PA
18936
|
|
Correspondent Contact |
JILLIAN MIKOVICH |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 04/12/2012 |
Decision Date | 12/18/2012 |
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
|
|
|