The following data is part of a premarket notification filed by Personal Products Co., Div. Of Mcneil Ppc, Inc. with the FDA for K-y Brand Warming Liquid Personal Lubricant.
| Device ID | K021492 |
| 510k Number | K021492 |
| Device Name: | K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | PERSONAL PRODUCTS CO., DIV. OF MCNEIL PPC, INC. 199 GRANDVIEW RD. Skillman, NJ 08558 -9418 |
| Contact | Marylou Panico |
| Correspondent | Marylou Panico PERSONAL PRODUCTS CO., 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 | 2002-05-09 |
| Decision Date | 2002-08-07 |
| Summary: | summary |