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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical, Active, Urological
510(k) Number K050910
Device Name ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS
Applicant
Roei Medical Technologies, Ltd.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact JONATHAN S KAHN
Correspondent
Roei Medical Technologies, Ltd.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact JONATHAN S KAHN
Regulation Number876.4300
Classification Product Code
FAS  
Date Received04/11/2005
Decision Date 06/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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