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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, nerve
510(k) Number K971143
Device Name NEURO PULSE II,III
Applicant
AARON MEDICAL INDUSTRIES
7100 30TH AVE. NORTH
ST. PETERSBURG,  FL  33710
Applicant Contact J. R SARON
Correspondent
AARON MEDICAL INDUSTRIES
7100 30TH AVE. NORTH
ST. PETERSBURG,  FL  33710
Correspondent Contact J. R SARON
Regulation Number874.1820
Classification Product Code
ETN  
Date Received03/28/1997
Decision Date 06/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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