Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K864364 |
Device Name |
WINDSOR SAFETY-TOP ENTERAL FEEDING BAG/BAG & SET |
Applicant |
TECHNICAL ASSOCIATES OF NEW ENGLAND |
P.O. BOX 116 |
HOPKINTON,
MA
01748
|
|
Applicant Contact |
ALLAN T SCHWINN |
Correspondent |
TECHNICAL ASSOCIATES OF NEW ENGLAND |
P.O. BOX 116 |
HOPKINTON,
MA
01748
|
|
Correspondent Contact |
ALLAN T SCHWINN |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 11/05/1986 |
Decision Date | 02/11/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|