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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocautery, gynecologic (and accessories)
510(k) Number K942986
Device Name ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)
Applicant
AARON MEDICAL INDUSTRIES
7100 30TH AVE. NORTH
ST. PETERSBURG,  FL  33710
Applicant Contact J. ROBERT SARON
Correspondent
AARON MEDICAL INDUSTRIES
7100 30TH AVE. NORTH
ST. PETERSBURG,  FL  33710
Correspondent Contact J. ROBERT SARON
Regulation Number884.4120
Classification Product Code
HGI  
Date Received06/01/1994
Decision Date 03/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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