
Louis M. Gerson Co., Inc.
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ISOLAIR APR TYPE N95 is an FDA 510(k)-cleared medical device (K960778) 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 May 8, 1996. Regulation: 8.