FDA 510(k) Applications Submitted by Rebecca Odulio

FDA 510(k) Number Submission Date Device Name Applicant
K250752 03/12/2025 AURORA« Surgiscope« System (ASX15/60); AURORA« Surgiscope« System (ASX15/80) Integra LifeSciences Corporation
K182399 09/04/2018 Park Blade Septostomy Catheter Cook Incorporated
K171602 06/01/2017 Williams Cystoscopic Injection Needle Cook Incorporated
K172527 08/21/2017 Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe Cook Incorporated
K180216 01/25/2018 Seidmon Antegrade AQ Stent Set Cook Incorporated


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