Device Classification Name |
Filter, Infusion Line
|
510(k) Number |
K113227 |
Device Name |
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER |
Applicant |
BAXTER HEALTHCARE CORP. |
1 BAXTER PKWY. |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
NANETTE HEDDEN |
Correspondent |
BAXTER HEALTHCARE CORP. |
1 BAXTER PKWY. |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
NANETTE HEDDEN |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 11/01/2011 |
Decision Date | 12/08/2011 |
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
|
|
|