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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 K971079
Device Name INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE
Applicant
INTERLOGICS, INC.
P.O. BOX 1239
HILLSBOROUGH,  NC  27278
Applicant Contact DONALD R MCINTYRE
Correspondent
INTERLOGICS, INC.
P.O. BOX 1239
HILLSBOROUGH,  NC  27278
Correspondent Contact DONALD R MCINTYRE
Regulation Number888.1500
Classification Product Code
KQX  
Date Received03/25/1997
Decision Date 07/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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