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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
Model TBD
Device Name AQUAMANTYS3 9.5 XL BIPOLAR SEALER
Applicant
MEDTRONIC INC.
180 international dr
portsmouth,  NH  03801
Contact tara n turney, rac
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/24/2012
Decision Date 05/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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