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FDA 510(k) Applications Submitted by Angela Johnson
FDA 510(k) Number
Submission Date
Device Name
Applicant
K191175
05/01/2019
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
ACIST Medical Systems, Inc.
K193183
11/18/2019
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
ACIST Medical Systems, Inc.
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