The following data is part of a premarket notification filed by Mcneil-ppc, Inc. with the FDA for K-y Brand Sensual Mist.
| Device ID | K053397 |
| 510k Number | K053397 |
| Device Name: | K-Y BRAND SENSUAL MIST |
| Classification | Lubricant, Personal |
| Applicant | MCNEIL-PPC, INC. 199 GRANDVIEW RD. Skillman, NJ 08558 |
| Contact | Nader Fotouhi |
| Correspondent | Nader Fotouhi MCNEIL-PPC, INC. 199 GRANDVIEW RD. Skillman, NJ 08558 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-06 |
| Decision Date | 2006-02-17 |
| Summary: | summary |