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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Platform, Force-Measuring
510(k) Number K930089
Device Name SMS BALANCE PERFORMANCE MONITOR
Applicant
Sms Technologies, Ltd.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact TOBY JOHNSTON
Correspondent
Sms Technologies, Ltd.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact TOBY JOHNSTON
Regulation Number890.1575
Classification Product Code
KHX  
Date Received01/08/1993
Decision Date 06/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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