
Exact Medical Manufacturing, Inc.
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EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER is an FDA 510(k)-cleared medical device (K111535) 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 August 25, 2011. Regulation: 8.