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FDA 510(k) Application Details - K182324
Device Classification Name
More FDA Info for this Device
510(K) Number
K182324
Device Name
EkoSonic Endovascular System
Applicant
BTG International, Inc.
11911 N Creek Pkwy S
Bothell, WA 98011 US
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Contact
Benjamin Hornsey
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Regulation Number
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Classification Product Code
QEY
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Date Received
08/27/2018
Decision Date
11/26/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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