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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 K100275
Device Name WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS
Applicant
Olympus Winter &Ibe GmbH
3500 Corporate Pkway
P.O. Box 610
Center Valley,  PA  18034 -0610
Applicant Contact STACY KLUESNER
Correspondent
Olympus Winter &Ibe GmbH
3500 Corporate Pkway
P.O. Box 610
Center Valley,  PA  18034 -0610
Correspondent Contact STACY KLUESNER
Regulation Number876.4300
Classification Product Code
FAS  
Subsequent Product Code
GEI  
Date Received02/01/2010
Decision Date 07/01/2010
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
Recalls CDRH Recalls
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