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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 K920256
Device Name SPINE MOTION ANALYZER WITH EMG
Applicant
ORTHOPEDIC SYSTEMS, INC.
1897 NATIONAL AVE.
HAYWARD,  CA  94545
Applicant Contact ROBERT R MOORE
Correspondent
ORTHOPEDIC SYSTEMS, INC.
1897 NATIONAL AVE.
HAYWARD,  CA  94545
Correspondent Contact ROBERT R MOORE
Regulation Number888.1500
Classification Product Code
KQX  
Date Received01/21/1992
Decision Date 08/10/1992
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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