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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 K121290
Device Name AQUAMANTRYS3 BSC 9.1S
Original Applicant
MEDTRONIC INC.
180 international drive
portsmouth,  NH  03801
Original Contact tara n turney
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/30/2012
Decision Date 06/25/2012
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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