
Havel'S, Inc.
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ECHOSTIM FACET TIP is an FDA 510(k)-cleared medical device (K063380) manufactured by Havel'S, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 24, 2007. Regulation: 8.