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FDA 510(k) Application Details - K191119
Device Classification Name
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510(K) Number
K191119
Device Name
EkoSonic Endovascular Device
Applicant
BTG International, Inc.
11911 North Creek Parkway S
Bothell, WA 98011 US
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Contact
Joshua Kim
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Regulation Number
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Classification Product Code
QEY
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Date Received
04/26/2019
Decision Date
08/23/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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