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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 K946229
Device Name BALANCE MANAGER
Applicant
Neurocom International, Inc.
9570 SE Lawnfield Rd.
Clackamas,  OR  97015
Applicant Contact JACK FASSEL
Correspondent
Neurocom International, Inc.
9570 SE Lawnfield Rd.
Clackamas,  OR  97015
Correspondent Contact JACK FASSEL
Regulation Number890.1575
Classification Product Code
KHX  
Subsequent Product Code
LXV  
Date Received12/22/1994
Decision Date 08/04/1995
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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