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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 K905045
Device Name NERVE LOCATOR/STIMULATOR
Applicant
AARON MEDICAL INDUSTRIES
1640 CENTRAL AVE.
ST. PETERSBURG,  FL  33712
Applicant Contact ROBERT SARON
Correspondent
AARON MEDICAL INDUSTRIES
1640 CENTRAL AVE.
ST. PETERSBURG,  FL  33712
Correspondent Contact ROBERT SARON
Regulation Number874.1820
Classification Product Code
ETN  
Date Received11/08/1990
Decision Date 03/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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