FDA 510(k) Application Details - K091856

Device Classification Name Electrode, Electrocardiograph

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510(K) Number K091856
Device Name Electrode, Electrocardiograph
Applicant CONMED CORPORATION
525 FRENCH RD.
UTICA, NY 13502 US
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Contact SANDRA COVELESKI
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Regulation Number 870.2360

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Classification Product Code DRX
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Date Received 06/23/2009
Decision Date 08/07/2009
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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