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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 K143580
Device Name PeriCoach
Applicant
ANALYTICA LTD
320 ADELAIDE STREET
BRISBANE,  AU 4000
Applicant Contact GEOFF DALY
Correspondent
Brandwood Biomedical
408, 406 Pacific Highway
St Leonards,  AU 2065
Correspondent Contact Tracey Bullivant
Regulation Number884.1425
Classification Product Code
HIR  
Date Received12/18/2014
Decision Date 03/18/2015
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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