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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lubricant, personal
510(k) Number K171516
Device Name Flip Lube
Imquest Biosciences Inc.
7340 Executive Way, Suite R
Frederick,  MD  21704
Applicant Contact Karen W. Buckheit
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
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