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FDA 510(k) Application Details - K180138
Device Classification Name
Device, Surgical, Cryogenic
More FDA Info for this Device
510(K) Number
K180138
Device Name
Device, Surgical, Cryogenic
Applicant
AtriCure, Inc.
7555 Innovation Way
Mason, OH 45040 US
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Contact
Melissa Smallwood
Other 510(k) Applications for this Contact
Regulation Number
882.4250
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Classification Product Code
GXH
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More FDA Info for this Product Code
Date Received
01/17/2018
Decision Date
02/15/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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