Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K072320 |
Device Name |
GREINER VACUETTE QUICKSHIELD COMPLETE |
Applicant |
GREINER BIO-ONE NORTH AMERICA, INC. |
P.O. BOX 103 |
BALDWIN,
MD
21013
|
|
Applicant Contact |
Judi Smith |
Correspondent |
GREINER BIO-ONE NORTH AMERICA, INC. |
P.O. BOX 103 |
BALDWIN,
MD
21013
|
|
Correspondent Contact |
Judi Smith |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 08/20/2007 |
Decision Date | 09/14/2007 |
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
|
Recalls |
CDRH Recalls
|
|
|