Device Classification Name |
Tube, Feeding
|
510(k) Number |
K003311 |
Device Name |
NUTRISAFE PUR ENTERAL FEEDING TUBE |
Applicant |
VYGON CORP. |
1129 BLOOMFIELD AVE. |
WEST CALDWELL,
NJ
07006
|
|
Applicant Contact |
ROBERT SCHIFF |
Correspondent |
VYGON CORP. |
1129 BLOOMFIELD AVE. |
WEST CALDWELL,
NJ
07006
|
|
Correspondent Contact |
ROBERT SCHIFF |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 10/23/2000 |
Decision Date | 01/11/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|