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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 K913079
Device Name 02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360
Applicant
Lucas Sensing Systems, Inc.
21640 N. 14th Ave.
Phoenix,  AZ  85027
Applicant Contact WAYNE SALUTE
Correspondent
Lucas Sensing Systems, Inc.
21640 N. 14th Ave.
Phoenix,  AZ  85027
Correspondent Contact WAYNE SALUTE
Regulation Number888.1500
Classification Product Code
KQX  
Date Received07/11/1991
Decision Date 09/25/1991
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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