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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 K950455
Device Name DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES
Applicant
Aaron Medical Industries
7100 30th Ave. N
St. Petersburg,  FL  33710
Applicant Contact J. ROBERT SARON
Correspondent
Aaron Medical Industries
7100 30th Ave. N
St. Petersburg,  FL  33710
Correspondent Contact J. ROBERT SARON
Regulation Number878.4400
Classification Product Code
JOS  
Date Received02/03/1995
Decision Date 05/16/1995
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
Predetermined Change
Control Plan Authorized		 No
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