Device Classification Name |
pump, infusion, insulin
|
510(k) Number |
K041318 |
Device Name |
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP |
Applicant |
MEDTRONIC MINIMED |
18000 DEVONSHIRE ST. |
NORTHRIDGE,
CA
91325 -1219
|
|
Applicant Contact |
MARK J FAILLACE |
Correspondent |
MEDTRONIC MINIMED |
18000 DEVONSHIRE ST. |
NORTHRIDGE,
CA
91325 -1219
|
|
Correspondent Contact |
MARK J FAILLACE |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 05/18/2004 |
Decision Date | 07/19/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|