
Sri/Surgical Express, Inc.
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SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN is an FDA 510(k)-cleared medical device (K023635) manufactured by Sri/Surgical Express, 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 November 17, 2002. Regulation: 8.