The following data is part of a premarket notification filed by Ssl Americas with the FDA for Durex Play Soft & Sensual Lubricant.
| Device ID | K071626 |
| 510k Number | K071626 |
| Device Name: | DUREX PLAY SOFT & SENSUAL LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | SSL AMERICAS 3583 ENGINEERING DR. SUITE 200 Norcross, GA 30092 |
| Contact | Chris Robinson |
| Correspondent | Chris Robinson SSL AMERICAS 3583 ENGINEERING DR. SUITE 200 Norcross, GA 30092 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-14 |
| Decision Date | 2008-04-01 |
| Summary: | summary |