Device Classification Name |
tube, feeding
|
510(k) Number |
K060944 |
Device Name |
NUTRISAFE 2 |
Applicant |
VYGON CORP. |
2495 GENERAL ARMISTEAD AVE |
NORRISTOWN,
PA
19403
|
|
Applicant Contact |
COURTNEY SMITH |
Correspondent |
VYGON CORP. |
2495 GENERAL ARMISTEAD AVE |
NORRISTOWN,
PA
19403
|
|
Correspondent Contact |
COURTNEY SMITH |
Regulation Number | 876.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/06/2006 |
Decision Date | 09/15/2006 |
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
|
Recalls |
CDRH Recalls
|
|
|