
Siemens Elema AB
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SIEMENS-ELEMA ENDOCARDIAL LEAD 402S is an FDA 510(k)-cleared medical device (K803042) manufactured by Siemens Elema AB. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on December 21, 1980. Regulation: 8.

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