FDA 510(k) Application Details - K142203

Device Classification Name Device, Surgical, Cryogenic

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510(K) Number K142203
Device Name Device, Surgical, Cryogenic
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 882.4250

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Classification Product Code GXH
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Date Received 08/11/2014
Decision Date 11/25/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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