
Tecnol Medical Products, Inc.
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PCM 2000; ISOLAIR APR MODEL 2735 is an FDA 510(k)-cleared medical device (K970448) manufactured by Tecnol Medical Products, 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 April 29, 1997. Regulation: 8.