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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perineometer
510(k) Number K140780
Device Name KEGEL SMART, KEGELSMART PEARL
Applicant
Regulatory Insight, Inc.
33 Golden Eagle Ln.
Littleton,  CO  80127
Applicant Contact Kevin Walls
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Ln.
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number884.1425
Classification Product Code
HIR  
Date Received03/28/2014
Decision Date 09/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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