
Avi, Inc.
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GUARDIAN 110, VOL. CONTROL DELIV. SYS is an FDA 510(k)-cleared medical device (K823406) manufactured by Avi, 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 December 21, 1982. Regulation: 8.

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