The following data is part of a premarket notification filed by Johnson & Johnson Consumer & Personal Products Wor with the FDA for K-y Brand Long Lasting Vaginal Moisturizer.
| Device ID | K101585 |
| 510k Number | K101585 |
| Device Name: | K-Y BRAND LONG LASTING VAGINAL MOISTURIZER |
| Classification | Lubricant, Personal |
| Applicant | JOHNSON & JOHNSON CONSUMER & PERSONAL PRODUCTS WOR 185 TABOR ROAD Morris Plains, NJ 07950 |
| Contact | Brad Lamotte,pharm.d. |
| Correspondent | Brad Lamotte,pharm.d. JOHNSON & JOHNSON CONSUMER & PERSONAL PRODUCTS WOR 185 TABOR ROAD Morris Plains, NJ 07950 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-07 |
| Decision Date | 2011-05-10 |
| Summary: | summary |