The following data is part of a premarket notification filed by Valencia Naturals, Inc with the FDA for Sensuva Premium Silicone Personal Lubricant.
Device ID | K212260 |
510k Number | K212260 |
Device Name: | Sensuva Premium Silicone Personal Lubricant |
Classification | Lubricant, Personal |
Applicant | Valencia Naturals, Inc 9731 Topanga Canyon Place Chatsworth, CA 91311 |
Contact | Anthony Santoro |
Correspondent | Stephanie Morris SLMCO Inc 19762 Steinway Street Canyon Country, CA 91351 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-07-20 |
Decision Date | 2022-04-13 |