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FDA 510(k) Application Details - K220699
Device Classification Name
Device, Vascular, For Promoting Embolization
More FDA Info for this Device
510(K) Number
K220699
Device Name
Device, Vascular, For Promoting Embolization
Applicant
Bait USA, LLC
29 Parker
Irvine, CA 92618 US
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Contact
Michael Peters
Other 510(k) Applications for this Contact
Regulation Number
870.3300
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Classification Product Code
KRD
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More FDA Info for this Product Code
Date Received
03/10/2022
Decision Date
04/08/2022
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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