The following data is part of a premarket notification filed by Ansell Healthcare Products, Llc with the FDA for Lifestyles Smooth 2-in-1 Massage & Lubricant.
| Device ID | K122476 |
| 510k Number | K122476 |
| Device Name: | LIFESTYLES SMOOTH 2-IN-1 MASSAGE & 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 | 2012-08-14 |
| Decision Date | 2013-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10070907270056 | K122476 | 000 |
| 10070907207427 | K122476 | 000 |
| 10070907084011 | K122476 | 000 |