Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K183584 |
Device Name |
JO H2O Jelly 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 |
Stephanie Morris |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 12/21/2018 |
Decision Date | 04/17/2019 |
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
|
|
|