Device Classification Name |
lubricant, personal
|
510(k) Number |
K162235 |
Device Name |
LUVENA VAGINAL MOISTURIZER & LUBRICANT |
Applicant |
LACLEDE, INC. |
2103 E. UNIVERSITY DR. |
RANCHO DOMINGUEZ,
CA
90220
|
|
Applicant Contact |
MICHAEL PELLICO |
Correspondent |
LACLEDE, INC. |
2103 E. UNIVERSITY DR. |
RANCHO DOMINGUEZ,
CA
90220
|
|
Correspondent Contact |
MICHAEL PELLICO |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 08/09/2016 |
Decision Date | 03/24/2017 |
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
|
|
|