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FDA 510(k) Application Details - K160309
Device Classification Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
More FDA Info for this Device
510(K) Number
K160309
Device Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant
TeleEMG, LLC
27 Arlington Rd., Building 2, Unit 1
Woburn, MA 01801 US
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Contact
Joe F Jabre
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Regulation Number
882.5805
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Classification Product Code
OBP
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More FDA Info for this Product Code
Date Received
02/04/2016
Decision Date
12/22/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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