
Exact Medical Manufacturing, Inc.
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EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL is an FDA 510(k)-cleared medical device (K101593) 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 September 2, 2010. Regulation: 8.