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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Goniometer, Ac-Powered
510(k) Number K893455
Device Name THE HANDSCAN SYSTEM
Applicant
Digital Body Systems, Inc.
1585 Woodlake Dr.
Suite 206
St. Louis,  MO  63017
Applicant Contact T HALAGERA
Correspondent
Digital Body Systems, Inc.
1585 Woodlake Dr.
Suite 206
St. Louis,  MO  63017
Correspondent Contact T HALAGERA
Regulation Number888.1500
Classification Product Code
KQX  
Date Received05/03/1989
Decision Date 08/30/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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