Device Classification Name |
Syringe, Piston
|
510(k) Number |
K051574 |
Device Name |
NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE |
Applicant |
NIPRO MEDICAL CORP. |
1384 COPPERFIELD COURT |
LEXINGTON,
KY
40514 -1268
|
|
Applicant Contact |
KAELYN HADLEY |
Correspondent |
NIPRO MEDICAL CORP. |
1384 COPPERFIELD COURT |
LEXINGTON,
KY
40514 -1268
|
|
Correspondent Contact |
KAELYN HADLEY |
Regulation Number | 880.5860
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/14/2005 |
Decision Date | 08/26/2005 |
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
|
|
|