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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 K933063
Device Name ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA
Applicant
ISOTECHNOLOGIES, INC.
P.O. BOX 1239
HILLSBOROUGH,  NC  27278
Applicant Contact GEORGE FLEMING
Correspondent
ISOTECHNOLOGIES, INC.
P.O. BOX 1239
HILLSBOROUGH,  NC  27278
Correspondent Contact GEORGE FLEMING
Regulation Number888.1500
Classification Product Code
KQX  
Date Received06/22/1993
Decision Date 01/27/1994
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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