The following data is part of a premarket notification filed by Personal Products Company, Div. Of Mcneil-ppc, Inc with the FDA for K-y Brand Warming Ultragel Personal Lubricant.
| Device ID | K040340 |
| 510k Number | K040340 |
| Device Name: | K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | PERSONAL PRODUCTS COMPANY, DIV. OF MCNEIL-PPC, INC 199 GRANDVIEW RD. Skillman, NJ 08558 -9418 |
| Contact | Marylou (panico) Carlson |
| Correspondent | Marylou (panico) Carlson PERSONAL PRODUCTS COMPANY, DIV. OF MCNEIL-PPC, INC 199 GRANDVIEW RD. Skillman, NJ 08558 -9418 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-11 |
| Decision Date | 2004-04-28 |
| Summary: | summary |