
Central Georgia Ancillary Health Systems
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STERILE SURGICAL GOWN PACK is an FDA 510(k)-cleared medical device (K911131) manufactured by Central Georgia Ancillary Health Systems. 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 15, 1991. Regulation: 8.