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FDA 510(k) Application Details - K200771
Device Classification Name
More FDA Info for this Device
510(K) Number
K200771
Device Name
Indigo Aspiration System Lightning Aspiration Tubing
Applicant
Penumbra, Inc.
One Penumbra Place
Alameda, CA 94502 US
Other 510(k) Applications for this Company
Contact
Micaela Victoria
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Regulation Number
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Classification Product Code
QEW
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Date Received
03/25/2020
Decision Date
04/22/2020
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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