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FDA 510(k) Application Details - K200083
Device Classification Name
Device, Vascular, For Promoting Embolization
More FDA Info for this Device
510(K) Number
K200083
Device Name
Device, Vascular, For Promoting Embolization
Applicant
Embolic Acceleration, LLC
3451 Commerce Pkwy
Miramar, FL 33025 US
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Contact
Veronica McDougall
Other 510(k) Applications for this Contact
Regulation Number
870.3300
More FDA Info for this Regulation Number
Classification Product Code
KRD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/15/2020
Decision Date
02/14/2020
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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