Device Classification Name |
Accessories, Pump, Infusion
|
510(k) Number |
K120209 |
Device Name |
PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE |
Applicant |
AMERICAN I.V. PRODUCTS, INC. |
7485 SHIPLEY AVE. |
HARMANS,
MD
21077
|
|
Applicant Contact |
MAJDI SHOMALI |
Correspondent |
AMERICAN I.V. PRODUCTS, INC. |
7485 SHIPLEY AVE. |
HARMANS,
MD
21077
|
|
Correspondent Contact |
MAJDI SHOMALI |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 01/24/2012 |
Decision Date | 04/12/2012 |
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
|
|
|