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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
Model TBD
Device Name PKS BILL
Original Applicant
GYRUS ACMI, INC.
136 turnpike rd.
southborough,  MA  01772
Original Contact neil kelly
Regulation Number884.4150
Classification Product Code
HIN  
Date Received08/27/2012
Decision Date 12/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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