FDA 510(k) Application Details - K040249

Device Classification Name Electrode, Electrocardiograph

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510(K) Number K040249
Device Name Electrode, Electrocardiograph
Applicant LEONHARD LANG GMBH
P.O. BOX 560
STILLWATER, MN 55082-0560 US
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Contact ELAINE DUNCAN
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Regulation Number 870.2360

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Classification Product Code DRX
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Date Received 02/03/2004
Decision Date 02/24/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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