
Genadyne Biotechnologies, Inc.
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XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and is an FDA 510(k)-cleared medical device (K142646) manufactured by Genadyne Biotechnologies, 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 29, 2015. Regulation: 8.