FDA 510(k) Application Details - K180010

Device Classification Name Clip, Implantable

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510(K) Number K180010
Device Name Clip, Implantable
Applicant AtriCure, Inc.
7555 Innovation Way
Mason, OH 45040 US
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Contact Brittany Lowe
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 01/02/2018
Decision Date 01/31/2018
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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