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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ligator, hemorrhoidal
510(k) Number K122660
Model M00522600, M00522601, M00522602, M00522610, 00522611, M00522612
Device Name RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
Original Applicant
100 boston scientific way
marlborough,  MA  01752
Original Contact thomas hirte
Regulation Number876.4400
Classification Product Code
Subsequent Product Code
Date Received08/31/2012
Decision Date 12/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No