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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transcranial magnetic stimulator
510(k) Number K061053
Device Name NEUROSTAR TMS SYSTEM
Original Applicant
NEURONETICS
one great valley pkwy.
ste.2
malvern,  PA  19355
Original Contact judy p ways
Regulation Number882.5805
Classification Product Code
OBP  
Date Received04/17/2006
Decision Date 10/07/2008
Decision de novo petitions granted (AN)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
FOI Item Approval Letter
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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