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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K060117
Device Name BOVIE BUTTON REMOTE HAND SWITCH
Applicant
AARON MEDICAL INDUSTRIES
7100 30TH AVE. NORTH
ST. PETERSBURG,  FL  33710 -2902
Applicant Contact RICHARD A KOZLOFF
Correspondent
INTERTEK TESTING SERVICES
70 CODMAN HILL RD.
BOXBOROUGH,  MA  01719
Correspondent Contact NEIL E DEVINE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/17/2006
Decision Date 02/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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