Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 K192779
Device Name Bunny Wax Personal Lubricant
Applicant
Reoxcyn, LLC
1488 W. Pleasant View Dr., Sutie 150
Pleasant Grove,  UT  84062
Applicant Contact Ellie Hartz
Correspondent
Morgan, Lewis, & Bockius, Llp
1111 Pennsylvania Ave., NW
Washington,  DC  20004
Correspondent Contact Ryan M Fournier
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/30/2019
Decision Date 06/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-