The following data is part of a premarket notification filed by Ansell Healthcare Products, Llc with the FDA for Lifestyles Natural Personal Lubricant.
| Device ID | K122054 |
| 510k Number | K122054 |
| Device Name: | LIFESTYLES NATURAL PERSONAL LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | ANSELL HEALTHCARE PRODUCTS, LLC 4 LOS VERDES DRIVE San Luis Obispo, CA 93401 |
| Contact | Donna Digangi |
| Correspondent | Donna Digangi 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 | 2012-07-13 |
| Decision Date | 2013-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08859798100346 | K122054 | 000 |
| 08859798100674 | K122054 | 000 |