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U.S. Department of Health and Human Services

Device Classification under Section 513(f)(2)(de novo)

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Device Classification Name transcranial magnetic stimulator
De Novo Number DEN070003
510(K) Number K061053
Device Name NEUROSTAR TMS SYSTEM
Requester
NEURONETICS
one great valley pkwy.
ste.2
malvern,  PA  19355
Contact judy p ways
Regulation Number882.5805
Classification Product Code
OBP  
Date Received05/24/2007
Decision Date 10/07/2008
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
Type Post-NSE
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