Device Classification Name |
lubricant, personal
|
510(k) Number |
K192203 |
Device Name |
JO for Him H2O Gel Original Personal Lubricant |
Applicant |
United Consortium |
29000 N. Hancock Pkwy. |
Valencia,
CA
91355
|
|
Applicant Contact |
Stephanie Morris |
Correspondent |
United Consortium |
29000 N. Hancock Pkwy. |
Valencia,
CA
91355
|
|
Correspondent Contact |
Marlent Perez |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 08/14/2019 |
Decision Date | 02/10/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|