The following data is part of a premarket notification filed by Necessaire, Inc. with the FDA for The Sex Gel.
| Device ID | K181078 |
| 510k Number | K181078 |
| Device Name: | The Sex Gel |
| Classification | Lubricant, Personal |
| Applicant | Necessaire, Inc. 10 Arbolo Court Manhattan Beach, CA 90266 |
| Contact | Randi Christiansen Stanley |
| Correspondent | Louie Goryoka Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-24 |
| Decision Date | 2018-09-10 |
| Summary: | summary |