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Louis M. Gerson Co., Inc.
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RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 is an FDA 510(k)-cleared medical device (K061375) manufactured by Louis M. Gerson Co., 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 November 16, 2006. Regulation: 8.