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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, biofeedback
510(k) Number K973537
Device Name PATHWAY ELECTROMYOGRAPH
Applicant
THE PROMETHEUS GROUP
2 MALLARDS COVE
DUXBURY,  MA  02332
Applicant Contact PETER A SULLIVAN
Correspondent
THE PROMETHEUS GROUP
2 MALLARDS COVE
DUXBURY,  MA  02332
Correspondent Contact PETER A SULLIVAN
Regulation Number882.5050
Classification Product Code
HCC  
Date Received09/18/1997
Decision Date 12/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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