Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K121511 |
Device Name |
MACLIN POWER INTRAVASCULAR ADMINISTRATION SET |
Applicant |
MACLIN POWER INC. |
VIA MARZIA, 9 |
ABANO TERME, PD,
IT
35031
|
|
Applicant Contact |
ENRICO BISSON |
Correspondent |
MACLIN POWER INC. |
VIA MARZIA, 9 |
ABANO TERME, PD,
IT
35031
|
|
Correspondent Contact |
ENRICO BISSON |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 05/21/2012 |
Decision Date | 03/07/2013 |
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
|
|
|