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 K171516
Device Name Flip Lube
Applicant
Imquest Biosciences, Inc.
7340 Executive Way, Suite R
Frederick,  MD  21704
Applicant Contact Karen W. Buckheit
Correspondent
Imquest Biosciences, Inc. C/O Promedical, LLC
24301 Woodsage Dr.
Bonita Springs,  FL  34134 -2958
Correspondent Contact Paul Dryden
Regulation Number884.5300
Classification Product Code
NUC  
Date Received05/24/2017
Decision Date 02/05/2018
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
Predetermined Change
Control Plan Authorized		 No
-
-