Device Classification Name |
Intrauterine Tamponade Balloon
|
510(k) Number |
K201199 |
FOIA Releasable 510(k) |
K201199
|
Device Name |
Jada System |
Applicant |
Alydia Health |
3495 Edison Way |
Menlo Park,
CA
94025
|
|
Applicant Contact |
Colby Holtshouse |
Correspondent |
Domecus Consulting Services LLC |
1171 Barroilhet Drive |
Hillsborough,
CA
94010
|
|
Correspondent Contact |
Cindy Domecus |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 05/04/2020 |
Decision Date | 08/28/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02883673 NCT04364386
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|