FDA 510(k) Application Details - K971143

Device Classification Name Stimulator, Nerve

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510(K) Number K971143
Device Name Stimulator, Nerve
Applicant AARON MEDICAL INDUSTRIES
7100 30TH AVE. NORTH
ST. PETERSBURG, FL 33710 US
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Contact J. R SARON
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Regulation Number 874.1820

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Classification Product Code ETN
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Date Received 03/28/1997
Decision Date 06/06/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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