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 K151884
Device Name K-Y Marilyn Pleasure Gel
Applicant
Reckitt Benckiser LLC
399 Interpace Parkway
Parsippany,  NJ  07054
Applicant Contact ELIZABETH TORRE
Correspondent
Reckitt Benckiser LLC
399 Interpace Parkway
Parsippany,  NJ  07054
Correspondent Contact ELIZABETH TORRE
Regulation Number884.5300
Classification Product Code
NUC  
Date Received07/09/2015
Decision Date 01/11/2016
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
-
-