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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 K984352
Device Name AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR
Applicant
Aaron Medical Industries
7100 30th Ave. N.
St. Petersburg,  FL  33710 -2902
Applicant Contact J. ROBERT SARON
Correspondent
Aaron Medical Industries
7100 30th Ave. N.
St. Petersburg,  FL  33710 -2902
Correspondent Contact J. ROBERT SARON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/04/1998
Decision Date 03/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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