
Strato/Infusaid, Inc.
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STRATO/INFUSAID TUNNELER is an FDA 510(k)-cleared medical device (K950987) manufactured by Strato/Infusaid, 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 June 1, 1995. Regulation: 8.

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