• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name lubricant, personal
510(k) Number K212260
Device Name Sensuva Premium Silicone Personal Lubricant
Valencia Naturals, Inc
9731 Topanga Canyon Place
Chatsworth,  CA  91311
Applicant Contact Anthony Santoro
19762 Steinway Street
Canyon Country,  CA  91351
Correspondent Contact Stephanie Morris
Regulation Number884.5300
Classification Product Code
Date Received07/20/2021
Decision Date 04/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No