Device Classification Name |
syringe, piston
|
510(k) Number |
K122373 |
Device Name |
NEOMED ORAL/ENTERAL SYRINGE |
Applicant |
NEOMED, INC. |
100 Londonderry Ct |
Suite 112 |
Woodstock,
GA
30188
|
|
Applicant Contact |
MELINDA HARRISON |
Correspondent |
NEOMED, INC. |
100 Londonderry Ct |
Suite 112 |
Woodstock,
GA
30188
|
|
Correspondent Contact |
MELINDA HARRISON |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 08/06/2012 |
Decision Date | 09/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|