The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Ultrasmooth Lubricating Liquid, And Medline Lubricating Liquid And Vaginal Moisturizer.
| Device ID | K143529 |
| 510k Number | K143529 |
| Device Name: | UltraSmooth Lubricating Liquid, And Medline Lubricating Liquid And Vaginal Moisturizer |
| Classification | Lubricant, Personal |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundlelein, IL 60060 |
| Contact | Jennifer Mason |
| Correspondent | Jennifer Mason MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundlelein, IL 60060 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-12 |
| Decision Date | 2015-08-21 |
| Summary: | summary |