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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 K080717
Device Name HABIB HEXABLATE 10
Applicant
Emcision , Ltd.
Liver Surgery, Hammersmith
Hospital Campus, Du Cane Rd.
London, Uk,  GB W12 OHS
Applicant Contact NAGY HABIB
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131 -1230
Correspondent Contact MORTEN S CHRISTENSEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/13/2008
Decision Date 03/27/2008
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
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