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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 K943898
Device Name SAUNDERS ELECTRONIC INCLINOMETER
Applicant
THE SAUNDERS GROUP
4250 NOREX DR.
CHASKA,  MN  55318 -3047
Applicant Contact T.L. MILLS
Correspondent
THE SAUNDERS GROUP
4250 NOREX DR.
CHASKA,  MN  55318 -3047
Correspondent Contact T.L. MILLS
Regulation Number888.1500
Classification Product Code
KQX  
Date Received08/10/1994
Decision Date 11/28/1994
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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