
Border Opportunity Saver Systems, Inc.
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STERILE DISPOSABLE SURGICAL GOWN W/ TOWEL is an FDA 510(k)-cleared medical device (K920568) manufactured by Border Opportunity Saver Systems, 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 October 21, 1992. Regulation: 8.