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 K161585
Device Name Mano and Mano Personal Lubricant
Applicant
Mano and Mano Proprietary Limited
286 Chesterville Road
Moorabbin,  AU 3189
Applicant Contact Katrina Allen
Correspondent
ClinReg Consulting Services, Inc.
733 Bolsana Drive
Laguna Beach,  CA  92651
Correspondent Contact Gary Mocnik
Regulation Number884.5300
Classification Product Code
NUC  
Date Received06/08/2016
Decision Date 09/06/2016
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
-
-