The following data is part of a premarket notification filed by Kimberly-clark Corporation with the FDA for Poise Personal Lubricant.
| Device ID | K120650 |
| 510k Number | K120650 |
| Device Name: | POISE PERSONAL LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | KIMBERLY-CLARK CORPORATION 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Swarna Mukund |
| Correspondent | Swarna Mukund KIMBERLY-CLARK CORPORATION 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-02 |
| Decision Date | 2012-07-11 |
| Summary: | summary |