Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K121803 |
Device Name |
INTRAVASCULAR ADMINISTRATION SET |
Applicant |
ACTA MEDICAL LLC |
15 MINNEAKONING RD. SUITE 203 |
FLEMINGTON,
NJ
08822
|
|
Applicant Contact |
JOHN BREWER |
Correspondent |
ACTA MEDICAL LLC |
15 MINNEAKONING RD. SUITE 203 |
FLEMINGTON,
NJ
08822
|
|
Correspondent Contact |
JOHN BREWER |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 06/19/2012 |
Decision Date | 12/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|