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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 K992485
Device Name MONOPOLAR ELECTRODES AND CABLES
Applicant
Us Endo, Inc.
826 Eagle Dr.
Bensenville,  IL  60106
Applicant Contact JONEL MANCIU
Correspondent
Us Endo, Inc.
826 Eagle Dr.
Bensenville,  IL  60106
Correspondent Contact JONEL MANCIU
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/26/1999
Decision Date 08/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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