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FDA 510(k) Application Details - K954388
Device Classification Name
Electrode, Electrocardiograph
More FDA Info for this Device
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.
Other 510(k) Applications for this Contact
Regulation Number
870.2360
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Classification Product Code
DRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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