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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 K120537
Device Name AQUAMANTYS3 9.5 XL BIPOLAR SEALER
Applicant
MEDTRONIC INC.
180 INTERNATIONAL DR
PORTSMOUTH,  NH  03801
Applicant Contact TARA N TURNEY, RAC
Correspondent
MEDTRONIC INC.
180 INTERNATIONAL DR
PORTSMOUTH,  NH  03801
Correspondent Contact TARA N TURNEY, RAC
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/22/2012
Decision Date 05/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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