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FDA 510(k) Application Details - K220807
Device Classification Name
More FDA Info for this Device
510(K) Number
K220807
Device Name
Imperative Care Radial 088 Access System
Applicant
Imperative Care Inc.
1359 Dell Avenue
Campbell, CA 95008 US
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Contact
Kristin Elis
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QJP
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More FDA Info for this Product Code
Date Received
03/18/2022
Decision Date
05/17/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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