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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 K920690
Device Name NOROTRACK 360 INCLINOMETER
Applicant
NOROMED, INC.
720 OLIVE WAY
SUITE 800
SEATTLE,  WA  98101
Applicant Contact ADIB
Correspondent
NOROMED, INC.
720 OLIVE WAY
SUITE 800
SEATTLE,  WA  98101
Correspondent Contact ADIB
Regulation Number888.1500
Classification Product Code
KQX  
Date Received02/14/1992
Decision Date 05/20/1992
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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