
Molnlycke Health Care Us, LLC
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Avance Solo Negative Pressure Wound Therapy (NPWT) System is an FDA 510(k)-cleared medical device (K203369) manufactured by Molnlycke Health Care Us, LLC. 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 June 30, 2021. Regulation: 8.