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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 K091074
Device Name AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES
Applicant
Encision, Inc.
6797 Winchester Cir.
Boulder,  CO  80301
Applicant Contact JUDITH KING
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact JAY KOGOMA
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/14/2009
Decision Date 08/17/2009
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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