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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K122203
Device Name TRUETOME
Original Applicant
100 boston scientific way
marlborough,  MA  01752
Original Contact laurie pannella
Regulation Number876.4300
Classification Product Code
Date Received07/25/2012
Decision Date 08/17/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No