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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 K051420
Device Name HABIB 4X
Applicant
Emcision , Ltd.
Ducane Rd.
London,  GB W12 0HS
Applicant Contact NAGY HABIB
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact CHANTEL CARSON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/01/2005
Decision Date 08/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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