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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name clip, implantable
510(k) Number K122276
Model PR0135, PR0140, PR0145, PRO150
Device Name ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
Original Applicant
ATRICURE, INC.
6217 centre park drive
west chester,  OH  45069
Original Contact james lucky
Regulation Number878.4300
Classification Product Code
FZP  
Date Received07/31/2012
Decision Date 08/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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