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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name coagulator-cutter, endoscopic, bipolar (and accessories)
510(k) Number K122605
Device Name PKS BILL
Original Applicant
136 turnpike rd.
southborough,  MA  01772
Original Contact neil kelly
Regulation Number884.4150
Classification Product Code
Date Received08/27/2012
Decision Date 12/05/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No