Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K113469 |
Device Name |
NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE |
Applicant |
NIPRO MEDICAL CORPORATION |
3150 N.W. 107TH AVE. |
MIAMI,
FL
33172
|
|
Applicant Contact |
JESSICA OSWALD |
Correspondent |
NIPRO MEDICAL CORPORATION |
3150 N.W. 107TH AVE. |
MIAMI,
FL
33172
|
|
Correspondent Contact |
JESSICA OSWALD |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 11/22/2011 |
Decision Date | 10/18/2012 |
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
|
|
|