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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 K945611
Device Name PERITRON
Applicant
Cardio Design Pty. , Ltd.
7089 Crowne Oak Rd.
Eden Prairie,  MN  55344
Applicant Contact STEPHAN NORSTED
Correspondent
Cardio Design Pty. , Ltd.
7089 Crowne Oak Rd.
Eden Prairie,  MN  55344
Correspondent Contact STEPHAN NORSTED
Regulation Number884.1425
Classification Product Code
HIR  
Date Received11/15/1994
Decision Date 02/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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