The following data is part of a premarket notification filed by Reckitt Benckiser, Llc with the FDA for Durex Realfeel Pleasure Gel Personal Lubricant.
| Device ID | K131643 |
| 510k Number | K131643 |
| Device Name: | DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | RECKITT BENCKISER, LLC 399 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Contact | Sapana Amin |
| Correspondent | Sapana Amin 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 | 2013-06-05 |
| Decision Date | 2014-12-17 |
| Summary: | summary |