Device Classification Name |
pump, infusion
|
510(k) Number |
K880623 |
Device Name |
MINIMED MODEL 404-SP EXTERNAL INFUSION PUMP |
Applicant |
MEDTRONIC MINIMED |
12744 SAN FERNANDO RD. |
SYLMAR,
CA
91342
|
|
Applicant Contact |
WILLIAM H DUFFELL |
Correspondent |
MEDTRONIC MINIMED |
12744 SAN FERNANDO RD. |
SYLMAR,
CA
91342
|
|
Correspondent Contact |
WILLIAM H DUFFELL |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 02/16/1988 |
Decision Date | 04/21/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|