| Device Classification Name |
Lubricant, Personal
|
| 510(k) Number |
K151857 |
| Device Name |
Love Alchemy's Love Lotion |
| Applicant |
| Love Alchemy, LLC |
| 421 Kingsley Ave. |
| #200 |
|
Orange Park,
FL
32073
|
|
| Applicant Contact |
Eric Weiss |
| Correspondent |
| Love Alchemy, LLC |
| 421 Kingsley Ave. |
| #200 |
|
Orange Park,
FL
32073
|
|
| Correspondent Contact |
Eric Weiss |
| Regulation Number | 884.5300 |
| Classification Product Code |
|
| Date Received | 07/08/2015 |
| Decision Date | 01/09/2017 |
| 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
|
Predetermined Change Control Plan Authorized |
No
|
|
|