FDA 510(k) Applications Submitted by Shajunath Nirupama

FDA 510(k) Number Submission Date Device Name Applicant
K201112 04/27/2020 AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP Arrow International Inc.
K222487 08/17/2022 Anika Tissue Tack Fixation System Anika Therapeutics, Inc.
K172903 09/22/2017 HemosIL D-Dimer HS 500 Instrumentation Laboratory Co.
K223860 12/23/2022 IntegrityÖ Bone Staple Fixation System Anika Therapeutics Inc.


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