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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 K894283
Device Name COMPREHENSIVE SPINE MOTION ANALYZER
Applicant
ORTHOPEDIC SYSTEMS, INC.
1897 NATIONAL AVE.
HAYWARD,  CA  94545
Applicant Contact ROBERT MOORE
Correspondent
ORTHOPEDIC SYSTEMS, INC.
1897 NATIONAL AVE.
HAYWARD,  CA  94545
Correspondent Contact ROBERT MOORE
Regulation Number888.1500
Classification Product Code
KQX  
Date Received06/23/1989
Decision Date 01/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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