Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K970849 |
Device Name |
ENTERAL NUTRITION 1000 ML/500ML |
Applicant |
MEDICAL INFUSION TECHNOLOGIES, INC. |
6576 EAST QUAKER ST. |
ORCHARD PARK,
NY
14127 -2593
|
|
Applicant Contact |
JOHN MCNEIRNEY |
Correspondent |
MEDICAL INFUSION TECHNOLOGIES, INC. |
6576 EAST QUAKER ST. |
ORCHARD PARK,
NY
14127 -2593
|
|
Correspondent Contact |
JOHN MCNEIRNEY |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 03/07/1997 |
Decision Date | 08/15/1997 |
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
|
|
|