FDA 510(k) Applications Submitted by Pragnya Bakka

FDA 510(k) Number Submission Date Device Name Applicant
K230914 03/31/2023 ARIS┐ COBLATION┐ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) Arthrocare Corporation
K231376 05/12/2023 Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) Smith & Nephew Inc.
K212204 07/15/2021 Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Cont CD Diagnostics Inc


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