The following data is part of a premarket notification filed by Personal Products Co. with the FDA for K-y Brand Warming Liquid.
| Device ID | K070545 |
| 510k Number | K070545 |
| Device Name: | K-Y BRAND WARMING LIQUID |
| Classification | Lubricant, Personal |
| Applicant | PERSONAL PRODUCTS CO. 199 GRANDVIEW RD. Skillman, NJ 08558 |
| Contact | Nader Fotouhi |
| Correspondent | Nader Fotouhi PERSONAL PRODUCTS CO. 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 | 2007-02-26 |
| Decision Date | 2007-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20067981087110 | K070545 | 000 |
| 20067981087103 | K070545 | 000 |
| 10067981087106 | K070545 | 000 |