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FDA 510(k) Application Details - K122276
Device Classification Name
Clip, Implantable
More FDA Info for this Device
510(K) Number
K122276
Device Name
Clip, Implantable
Applicant
ATRICURE, INC.
6217 CENTRE PARK DRIVE
WEST CHESTER, OH 45069 US
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Contact
JAMES LUCKY
Other 510(k) Applications for this Contact
Regulation Number
878.4300
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Classification Product Code
FZP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/30/2012
Decision Date
08/29/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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