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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 EAST AURORA ROAD
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
Recalls CDRH Recalls
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