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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 K071103
Device Name HABIB HEXABLATE
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 ROAD
SAN JOSE,  CA  95131 -1230
Correspondent Contact MORTEN SIMON CHRISTENSEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/19/2007
Decision Date 06/27/2007
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
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