FDA 510(k) Application Details - K153500

Device Classification Name Clip, Implantable

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510(K) Number K153500
Device Name Clip, Implantable
Applicant Atricure, Inc.
6217 Centre Park Drive
West Chester, OH 45069 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 12/07/2015
Decision Date 01/27/2016
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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