FDA 510(k) Application Details - K954388

Device Classification Name Electrode, Electrocardiograph

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510(K) Number K954388
Device Name Electrode, Electrocardiograph
Applicant CONMED CORP.
P.O. BOX 1408
DAYTON, OH 45401-1408 US
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Contact IRA D DUESLER, JR.
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Regulation Number 870.2360

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Classification Product Code DRX
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Date Received 09/19/1995
Decision Date 02/06/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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