Device Classification Name |
pump, infusion
|
510(k) Number |
K991936 |
Device Name |
3.0 ML RESERVOIR, MODEL 103/193 |
Applicant |
MEDTRONIC MINIMED |
12744 SAN FERNANDO RD. |
SYLMAR,
CA
91342
|
|
Applicant Contact |
JENNIFER LYONS |
Correspondent |
MEDTRONIC MINIMED |
12744 SAN FERNANDO RD. |
SYLMAR,
CA
91342
|
|
Correspondent Contact |
JENNIFER LYONS |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 06/09/1999 |
Decision Date | 01/18/2000 |
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
|
|
|