Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K002180 |
Device Name |
SIMPLICITY DISPOSABLE PEN NEEDLE |
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 | 880.5570
|
Classification Product Code |
|
Date Received | 07/19/2000 |
Decision Date | 10/13/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|