
Faulding Medical Device Co.
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SAFE-CONNECT I.V. EXTENSION SET is an FDA 510(k)-cleared medical device (K970524) manufactured by Faulding Medical Device Co.. 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 April 21, 1997. Regulation: 8.

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