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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K120909
Model 26-101-1
Device Name EC 2.7 ENDOSCOPIC CUTTER
Original Applicant
MEDTRONIC ADVANCED ENERGY, LLC
180 international drive
portsmouth,  NH  03801
Original Contact martin j leighton
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/26/2012
Decision Date 11/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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