
Davol, Inc.
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Bard Soft Mesh; Bard Soft Mesh Pre-Shaped is an FDA 510(k)-cleared medical device (K250098) manufactured by Davol, Inc.. 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 April 8, 2025. Regulation: 8.