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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 K961212
Device Name SPINAL TOUCH
Applicant
Fasstech
155 Middlesex Turnpike
Burlington,  MA  01803
Applicant Contact LEE R BRODY
Correspondent
Fasstech
155 Middlesex Turnpike
Burlington,  MA  01803
Correspondent Contact LEE R BRODY
Regulation Number888.1500
Classification Product Code
KQX  
Date Received03/28/1996
Decision Date 06/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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