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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
Device Name EC 2.7 ENDOSCOPIC CUTTER
Applicant
MEDTRONIC ADVANCED ENERGY, LLC
180 INTERNATIONAL DRIVE
PORTSMOUTH,  NH  03801
Applicant Contact MARTIN J LEIGHTON
Correspondent
MEDTRONIC ADVANCED ENERGY, LLC
180 INTERNATIONAL DRIVE
PORTSMOUTH,  NH  03801
Correspondent Contact MARTIN J LEIGHTON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/26/2012
Decision Date 11/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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