
Bolder Surgical, LLC
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CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) is an FDA 510(k)-cleared medical device (K211579) manufactured by Bolder Surgical, 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 September 6, 2021. Regulation: 8.