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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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