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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
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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