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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 K171896
Device Name Feminine Personal Trainer (FPT)
Applicant
Ralston Group
656 Lake Lanier Rd.
Selma,  AL  36701
Applicant Contact Russell Ralston
Correspondent
Intertek Surveying Services
16441 Space Center Blvd., Suite D-100
Houston,  TX  77058
Correspondent Contact Jennifer Tillman
Regulation Number884.1425
Classification Product Code
HIR  
Date Received06/26/2017
Decision Date 08/29/2017
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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