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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, unipolar (and accessories)
510(k) Number K121343
Model 4155
Device Name MODULAP LOOP
Original Applicant
ATC TECHNOLOGIES, INC.
79 haven street
dover,  MA  02030
Original Contact john gillespie
Regulation Number884.4160
Classification Product Code
KNF  
Date Received05/04/2012
Decision Date 06/14/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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