Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K121908 |
Device Name |
SAFETY INFUSION SET |
Applicant |
GREINER BIO-ONE NORTH AMERICA, INC. |
P.O. BOX 103 |
BALDWIN,
MD
21013
|
|
Applicant Contact |
JUDITH SMITH |
Correspondent |
GREINER BIO-ONE NORTH AMERICA, INC. |
P.O. BOX 103 |
BALDWIN,
MD
21013
|
|
Correspondent Contact |
JUDITH SMITH |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 06/29/2012 |
Decision Date | 07/25/2012 |
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
|
|
|