
Alleva Medical Devices
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extriCARE® 3000 Negative Wound Pressure Therapy System is an FDA 510(k)-cleared medical device (K221223) manufactured by Alleva Medical Devices. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 8, 2023. Regulation: 8.