FDA 510(k) Application Details - K111020

Device Classification Name Lamp, Surgical

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510(K) Number K111020
Device Name Lamp, Surgical
Applicant ATRICURE, INC.
6217 CENTRE PARK DRIVE
WEST CHESTER, OH 45069 US
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Contact JAMES L LUCKY
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Regulation Number 878.4580

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Classification Product Code FTD
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Date Received 04/12/2011
Decision Date 06/09/2011
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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