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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K072383
Device Name HABIB ENDOBLATE
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 SIMON CHRISTENSEN
Regulation Number876.4300
Classification Product Code
KNS  
Date Received08/24/2007
Decision Date 11/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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