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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name amplifier, physiological signal
510(k) Number K060374
Device Name REFA, PHYSIOLOGICAL AMPLIFIER
Applicant
TMS INTERNATIONAL BV
7744 SWAPS TRAIL
EVERGREEN,  CO  80439
Applicant Contact DAVID W WAGNER
Correspondent
TMS INTERNATIONAL BV
7744 SWAPS TRAIL
EVERGREEN,  CO  80439
Correspondent Contact DAVID W WAGNER
Regulation Number882.1835
Classification Product Code
GWL  
Date Received02/13/2006
Decision Date 05/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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