
Weck Closure Systems
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HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240 is an FDA 510(k)-cleared medical device (K003337) manufactured by Weck Closure Systems. 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 December 20, 2000. Regulation: 8.