The following data is part of a premarket notification filed by Laclede, Inc. with the FDA for Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant.
| Device ID | K150841 |
| 510k Number | K150841 |
| Device Name: | Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | LACLEDE, INC. 2103 EAST UNIVERSITY DR. Rancho Dominquez, CA 90220 |
| Contact | Michael Pellico |
| Correspondent | Seth A. Mailhot MICHAEL BEST & FRIEDRICH LLP 601 PENNSYLVANIA AVE NW SUITE 700 Washington, DC 20004 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-30 |
| Decision Date | 2015-12-29 |