Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K011187 |
Device Name |
SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS |
Applicant |
STERLING MEDIVATIONS, INC. |
180 FERNDALE RD. SOUTH |
WAYZATA,
MN
55391
|
|
Applicant Contact |
JOEL DOUGLAS |
Correspondent |
STERLING MEDIVATIONS, INC. |
180 FERNDALE RD. SOUTH |
WAYZATA,
MN
55391
|
|
Correspondent Contact |
JOEL DOUGLAS |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 04/18/2001 |
Decision Date | 06/19/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|