The following data is part of a premarket notification filed by Reckitt Benckiser with the FDA for K-y Brand Touch All-in-one Warming Caressing Creme And Personal Lubricant.
Device ID | K143511 |
510k Number | K143511 |
Device Name: | K-Y BRAND TOUCH All-in-one Warming Caressing Creme And Personal Lubricant |
Classification | Lubricant, Personal |
Applicant | RECKITT BENCKISER 399 INTERPACE PARKWAY Parsippany, NJ 07054 |
Contact | Elizabeth Torre |
Correspondent | Elizabeth Torre RECKITT BENCKISER 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 | 2014-12-11 |
Decision Date | 2015-05-20 |
Summary: | summary |