The following data is part of a premarket notification filed by Biotech Lubricants Ltd with the FDA for Yes Oil-based Personal Lubricant, Yes Water-based Personal Lubricant, Yes Vaginal Moisturizer.
| Device ID | K162569 |
| 510k Number | K162569 |
| Device Name: | YES Oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer |
| Classification | Lubricant, Personal |
| Applicant | BIOTECH LUBRICANTS LTD TRADEMARK HOUSE, RAMSHILL Petersfield, GB Gu31 4at |
| Contact | Sarah Brooks |
| Correspondent | Karen Cornelius MAETRICS BIOCITY NOTTINGHAM, PENNYFOOT STREET Nottingham, GB Ng1 1gf |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-15 |
| Decision Date | 2017-06-09 |
| Summary: | summary |