The following data is part of a premarket notification filed by Reckitt Benckiser Llc with the FDA for Durex Silicone.
| Device ID | K143532 |
| 510k Number | K143532 |
| Device Name: | Durex Silicone |
| Classification | Lubricant, Personal |
| Applicant | Reckitt Benckiser LLC 399 Interpace Parkway Parsippany, NJ 07054 |
| Contact | Elizabeth Torre |
| Correspondent | Elizabeth Torre Reckitt Benckiser LLC 399 Interpace Parkway Parsippany, NJ 07054 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-12 |
| Decision Date | 2015-07-31 |
| Summary: | summary |