Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K110656 |
Device Name |
IMC BLOOD COLLECTION NEEDLE |
Applicant |
INTERNATIONAL MEDSURG CONNECTION |
935 N PLUM GROVE ROAD |
SUITE F |
SCHAUMBURG,
IL
60173
|
|
Applicant Contact |
PETER KIM |
Correspondent |
INTERNATIONAL MEDSURG CONNECTION |
935 N PLUM GROVE ROAD |
SUITE F |
SCHAUMBURG,
IL
60173
|
|
Correspondent Contact |
PETER KIM |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 03/07/2011 |
Decision Date | 08/18/2011 |
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
|
|
|