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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 K942563
Device Name ELITE BIOFEEDBACK
Applicant
Laborie Medical Technologies, Ltd.
7 Green Tree Dr.
South Burlington,  VT  05403
Applicant Contact FRED BUFFA
Correspondent
Laborie Medical Technologies, Ltd.
7 Green Tree Dr.
South Burlington,  VT  05403
Correspondent Contact FRED BUFFA
Regulation Number884.1425
Classification Product Code
HIR  
Date Received05/31/1994
Decision Date 06/06/1995
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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