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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K872836
Device Name SPINOSCOPE
Applicant
Diagnospine Fabrication, Inc.
1980 Sherbrooke Quest,
Suite 1100, Montreal Qc.,
Canada H3h 1e8,  CA
Applicant Contact GRACOVETSKY
Correspondent
Diagnospine Fabrication, Inc.
1980 Sherbrooke Quest,
Suite 1100, Montreal Qc.,
Canada H3h 1e8,  CA
Correspondent Contact GRACOVETSKY
Regulation Number890.1375
Classification Product Code
IKN  
Date Received07/17/1987
Decision Date 09/29/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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