FDA 510(k) Application Details - K162797

Device Classification Name

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510(K) Number K162797
Device Name SpringTMS
Applicant eNeura Inc.
715 North Pastoria Avenue
Sunnyvale, CA 94085 US
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Contact Larry W. Getlin
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Regulation Number

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Classification Product Code OKP
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Date Received 10/04/2016
Decision Date 06/26/2017
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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