
Sunbronze
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SUNBRONZE SB24C/65 ULTRA is an FDA 510(k)-cleared medical device (K896983) manufactured by Sunbronze. 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 January 2, 1990. Regulation: 8.