
Manfred Sauer Corp.
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SKIN ADHESIVE-50XX is an FDA 510(k)-cleared medical device (K812249) manufactured by Manfred Sauer Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 22, 1981. Regulation: 8.