Device Classification Name |
lubricant, personal
|
510(k) Number |
K180712 |
Device Name |
Coconut Infused Hybrid 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 | 03/19/2018 |
Decision Date | 06/06/2018 |
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
|
|
|