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FDA 510(k) Application Details - K212288
Device Classification Name
More FDA Info for this Device
510(K) Number
K212288
Device Name
Minjie Catheter System
Applicant
Kai Medtech, LLC
22651 Lambert Street, Suite 107
Lake Forest, CA 92630 US
Other 510(k) Applications for this Company
Contact
Stephanie Rallis
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QJP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/21/2021
Decision Date
06/02/2022
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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