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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 K160758
Device Name PeriCoach OTC
Applicant
ANALYTICA LTD.
320 ADELAIDE STREET
BRISBANE,  AU 4000
Applicant Contact GEOFF DALY
Correspondent
BRANDWOOD BIOMEDICAL
SUITE 5, LEVEL 9, 1 CHANDOS STREET
ST LEONARDS,  AU 2065
Correspondent Contact TAMMY AHMADZADA
Regulation Number884.1425
Classification Product Code
HIR  
Date Received03/18/2016
Decision Date 07/11/2016
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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