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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 -2839
Applicant Contact WAYNE SALUTE
Correspondent
Lucas Sensing Systems, Inc.
21640 N. 14th Ave.
Phoenix,  AZ  85027 -2839
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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