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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 K901069
Device Name COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEM
Applicant
Computerized Functional Testing Corp.
2201 W. Campbell Park Dr.
Rm. 118
Chicago,  IL  60612
Applicant Contact THOMAS P ANDRIACCHI
Correspondent
Computerized Functional Testing Corp.
2201 W. Campbell Park Dr.
Rm. 118
Chicago,  IL  60612
Correspondent Contact THOMAS P ANDRIACCHI
Regulation Number890.1575
Classification Product Code
KHX  
Date Received03/07/1990
Decision Date 03/16/1990
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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