
Kay Borch A/S
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P1OP2B OR P1O92T is an FDA 510(k)-cleared medical device (K954674) manufactured by Kay Borch A/S. 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 January 29, 1997. Regulation: 8.