Device Classification Name |
Syringe, Piston
|
510(k) Number |
K000144 |
Device Name |
NIPRO INSULIN SYRINGE |
Applicant |
NIPRO MEDICAL CORP. |
3150 NW 107 AVE.. |
MIAMI,
FL
33172
|
|
Applicant Contact |
GARY GOLDSMITH |
Correspondent |
NIPRO MEDICAL CORP. |
3150 NW 107 AVE.. |
MIAMI,
FL
33172
|
|
Correspondent Contact |
GARY GOLDSMITH |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 01/18/2000 |
Decision Date | 02/11/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|