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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 K160703
Device Name NeuroStar TMS Therapy System
Applicant
NEURONETICS, INC.
3222 PHOENIXVILLE PIKE
Malvern,  PA  19355
Applicant Contact Judy P. Ways
Correspondent
NEURONETICS, INC.
3222 PHOENIXVILLE PIKE
Malvern,  PA  19355
Correspondent Contact Judy P. Ways
Regulation Number882.5805
Classification Product Code
OBP  
Date Received03/14/2016
Decision Date 06/10/2016
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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