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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 K133408
Device Name NEUROSTAR TMS THERAPY SYSTEM
Applicant
NEURONETICS
3222 PHOENIXVILLE PIKE
MALVERN,  PA  19355 -1245
Applicant Contact JUDY P WAYS, PH.D.
Correspondent
NEURONETICS
3222 PHOENIXVILLE PIKE
MALVERN,  PA  19355 -1245
Correspondent Contact JUDY P WAYS, PH.D.
Regulation Number882.5805
Classification Product Code
OBP  
Date Received11/06/2013
Decision Date 03/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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