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Exact Medical Manufacturing, Inc.
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EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV is an FDA 510(k)-cleared medical device (K120045) manufactured by Exact Medical Manufacturing, 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 June 11, 2012. Regulation: 8.