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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vibrator For Therapeutic Use, Genital
510(k) Number K110566
Device Name VIBERECT PENILE VIBRATORY STIMULATION DEVICE
Applicant
Reflexonic, LLC
611 W. 5th St. Third Floor
Austin,  TX  78701
Applicant Contact CAROLINE TONTINI
Correspondent
Reflexonic, LLC
611 W. 5th St. Third Floor
Austin,  TX  78701
Correspondent Contact CAROLINE TONTINI
Regulation Number884.5960
Classification Product Code
KXQ  
Date Received02/28/2011
Decision Date 06/24/2011
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
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