FDA 510(k) Application Details - K163261

Device Classification Name Clip, Implantable

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510(K) Number K163261
Device Name Clip, Implantable
Applicant ATRICURE INC.
7555 Innovation Way
Mason, OH 45040 US
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Contact Jonathan McElwee
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 11/21/2016
Decision Date 05/19/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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