FDA 510(k) Application Details - K110989

Device Classification Name Stimulator, Nerve

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510(K) Number K110989
Device Name Stimulator, Nerve
Applicant NEUROVISION MEDICAL PRODUCTS, INC.
2225 SPERRY AVE, SUITE 1000
VENTURA, CA 93003 US
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Contact CHRISTINE VERGELY
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Regulation Number 874.1820

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Classification Product Code ETN
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Date Received 04/08/2011
Decision Date 11/03/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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