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510(k) Premarket Notification

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Device Classification Name repetitive transcranial magnetic stimulator for treatment of major depressive disorder
510(k) NumberK061053
Device NameNEUROSTAR SYSTEM
Applicant
NEURONETICS
one great valley pkwy.
ste.2
malvern,  PA  19355
Contactjudy p ways
Regulation Number882.5805
Classification Product Code
OBP  
Date Received04/17/2006
Decision Date 04/26/2007
Decision cleared for marketing automatic class iii designat (AN)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
FOI ITEM LETTER
Type Cleared for Marketing Automatic Class III Designation
Reviewed by Third Party No
Expedited Review No
 
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