Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K871528 |
Device Name |
ENTRIMIT GRAVITY FEEDING SET |
Applicant |
BIOSEARCH MEDICAL PRODUCTS, INC. |
35 INDUSTRIAL PKWY. |
P.O. BOX 1700 |
SOMERVILLE,
NJ
08876
|
|
Applicant Contact |
ALBERTO VELEZ |
Correspondent |
BIOSEARCH MEDICAL PRODUCTS, INC. |
35 INDUSTRIAL PKWY. |
P.O. BOX 1700 |
SOMERVILLE,
NJ
08876
|
|
Correspondent Contact |
ALBERTO VELEZ |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 04/20/1987 |
Decision Date | 08/10/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|