The following data is part of a premarket notification filed by Laclede, Inc. with the FDA for Luvena Vaginal Moisturizer & Lubricant.
| Device ID | K162235 |
| 510k Number | K162235 |
| Device Name: | LUVENA VAGINAL MOISTURIZER & LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | LACLEDE, INC. 2103 E. UNIVERSITY DR. Rancho Dominguez, CA 90220 |
| Contact | Michael Pellico |
| Correspondent | Michael Pellico LACLEDE, INC. 2103 E. UNIVERSITY DR. Rancho Dominguez, CA 90220 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-09 |
| Decision Date | 2017-03-24 |
| Summary: | summary |