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FDA 510(k) Application Details - K091856
Device Classification Name
Electrode, Electrocardiograph
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.2360
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Classification Product Code
DRX
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More FDA Info for this Product Code
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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