
Omikron Scientific, Ltd.
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LITHIUM PACEMAKER 811-811L & 811XL is an FDA 510(k)-cleared medical device (K840748) manufactured by Omikron Scientific, Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on August 2, 1984. Regulation: 8.

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