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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 K100711
Device Name SUCTION IRRIGATION ELECTRODES AND ADAPTERS
Applicant
Encision, Inc.
6797 Winchester Cir.
Boulder,  CO  80301
Applicant Contact JUDITH V KING
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/12/2010
Decision Date 06/09/2010
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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