Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K161323 |
Device Name |
Solution Set for Epidural Use |
Applicant |
BAXTER HEALTHCARE CORPORATION |
32650 N. WILSON ROAD |
ROUND LAKE,
IL
60073
|
|
Applicant Contact |
Tiffany Lin |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 05/11/2016 |
Decision Date | 11/30/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|