Device Classification Name |
intrauterine tamponade balloon
|
510(k) Number |
K153591 |
Device Name |
ebb Complete Tamponade System |
Applicant |
CLINICAL INNOVATIONS, LLC |
747 WEST 4170 SOUTH |
MURRAY,
UT
84123
|
|
Applicant Contact |
TOM HAUETER |
Correspondent |
CLINICAL INNOVATIONS, LLC |
747 WEST 4170 SOUTH |
MURRAY,
UT
84123
|
|
Correspondent Contact |
TOM HAUETER |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 12/16/2015 |
Decision Date | 01/14/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|