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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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