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Isotis Orthobiologics, Inc.
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ASPIREX - BONE MARROW ASPIRATE KIT is an FDA 510(k)-cleared medical device (K041991) manufactured by Isotis Orthobiologics, Inc.. 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 September 15, 2004. Regulation: 8.

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