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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 K122383
Device Name EM3 AEM MONITOR AEM CONNECTORS
Applicant
Encision, Inc.
6797 Winchester Cir.
Boulder,  CO  80301
Applicant Contact JIM LEWIS
Correspondent
Encision, Inc.
6797 Winchester Cir.
Boulder,  CO  80301
Correspondent Contact JIM LEWIS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/06/2012
Decision Date 01/10/2013
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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