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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 K940812
Device Name INSIGHT ELECTRONIC ALIGNMENT INDICATOR
Applicant
ANDRONIC DEVICES, LTD.
SUITE 140
13120 VANIER PLACE
RICHMOND, B.C. CANADA V6V 2J2,  CA V6V 2J2
Applicant Contact ROBERT MACNEIL
Correspondent
ANDRONIC DEVICES, LTD.
SUITE 140
13120 VANIER PLACE
RICHMOND, B.C. CANADA V6V 2J2,  CA V6V 2J2
Correspondent Contact ROBERT MACNEIL
Regulation Number888.1500
Classification Product Code
KQX  
Date Received02/22/1994
Decision Date 11/21/1994
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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