
Burditt & Calkins-Siemens-Elema
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SIEMENS-ELMA PULSE GENERATOR #718 is an FDA 510(k)-cleared medical device (K830344) manufactured by Burditt & Calkins-Siemens-Elema. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on May 26, 1983. Regulation: 8.

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