Device Classification Name |
pump, infusion
|
510(k) Number |
K883587 |
Device Name |
BIOSEARCH 3600 ENTRI FEEDING PUMP |
Applicant |
BIOSEARCH MEDICAL PRODUCTS, INC. |
35 INDUSTRIAL PKWY. |
P.O. BOX 1700 |
SOMERVILLE,
NJ
08876
|
|
Applicant Contact |
JOHN CARSELLO |
Correspondent |
BIOSEARCH MEDICAL PRODUCTS, INC. |
35 INDUSTRIAL PKWY. |
P.O. BOX 1700 |
SOMERVILLE,
NJ
08876
|
|
Correspondent Contact |
JOHN CARSELLO |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 08/23/1988 |
Decision Date | 11/08/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|