Device Classification Name |
pump, infusion, insulin
|
510(k) Number |
K082590 |
Device Name |
SYMPHONY METER REMOTE |
Applicant |
LIFESCAN, INC. |
1000 GIBRALTAR DR. |
MILPITAS,
CA
95035 -6312
|
|
Applicant Contact |
MARTHA MURARI |
Correspondent |
LIFESCAN, INC. |
1000 GIBRALTAR DR. |
MILPITAS,
CA
95035 -6312
|
|
Correspondent Contact |
MARTHA MURARI |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/08/2008 |
Decision Date | 12/17/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|