The following data is part of a premarket notification filed by Ansell Healthcare Products Llc with the FDA for Lifestyles Warm Lovin Personal Lubricant.
| Device ID | K122720 |
| 510k Number | K122720 |
| Device Name: | LIFESTYLES WARM LOVIN PERSONAL LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | ANSELL HEALTHCARE PRODUCTS LLC 4 LOS VERDES DRIVE San Luis Obispo, CA 93401 |
| Contact | Donna Di Gangi |
| Correspondent | Donna Di Gangi ANSELL HEALTHCARE PRODUCTS LLC 4 LOS VERDES DRIVE San Luis Obispo, CA 93401 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-05 |
| Decision Date | 2013-02-22 |
| Summary: | summary |