FDA 510(k) Applications Submitted by Amanda Erwin

FDA 510(k) Number Submission Date Device Name Applicant
K221840 06/24/2022 Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves Integra LifeSciences Production Corporation
K233445 10/19/2023 Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter Integra LifeSciences Production Corporation
K233448 10/20/2023 Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set Integra LifeSciences Production Corporation
K223330 10/31/2022 Certas Plus Programmable Valves Integra LifeSciences Production Corporation


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