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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 K073687
Device Name HABIB LAPAROSCOPIC HEXABLATE
Applicant
EMCISION, LTD.
DU CANE ROAD
LONDON,  GB W12 0NN
Applicant Contact NAGY HABIB
Correspondent
UNDERWRITERS LABORATORIES, INC.
455 E. TRIMBLE ROAD
SAN JOSE,  CA  95131 -1230
Correspondent Contact MORTEN S CHRISTENSEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/28/2007
Decision Date 01/09/2008
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
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