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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name burr, corneal, battery-powered
510(k) Number K950520
Device Name BURR, CORNEAL, BATTERY-POWERED
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 Number886.4070
Classification Product Code
HOG  
Date Received02/06/1995
Decision Date 05/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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