
Pro-Safe Professional Linens, Inc.
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SURGICAL GOWN #2001 is an FDA 510(k)-cleared medical device (K891211) manufactured by Pro-Safe Professional Linens, 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 13, 1989. Regulation: 8.