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 Jelly Personal Lubricant.
| Device ID | K040164 |
| 510k Number | K040164 |
| Device Name: | K-Y BRAND WARMING JELLY PERSONAL LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | PERSONAL PRODUCTS COMPANY, DIV. OF MCNEIL-PPC, INC 199 GRANDVIEW RD. Skillman, NJ 08558 -9418 |
| Contact | Marylou P Carlson |
| Correspondent | Marylou P 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 | 2004-01-26 |
| Decision Date | 2004-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10067981089483 | K040164 | 000 |
| 10067981089476 | K040164 | 000 |
| 10067981993773 | K040164 | 000 |
| 77067981993778 | K040164 | 000 |
| 00067981089479 | K040164 | 000 |
| 77067981089488 | K040164 | 000 |