
Keisei (Usa) Co., Ltd.
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LIFE ISLAND 21 is an FDA 510(k)-cleared medical device (K925651) manufactured by Keisei (Usa) Co., Ltd.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 26, 1993. Regulation: 8.

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