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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, electrosurgical
510(k) Number K971187
Device Name STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE
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 Number878.4400
Classification Product Code
JOS  
Date Received04/01/1997
Decision Date 05/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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