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FDA 510(k) Application Details - K081762
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device
510(K) Number
K081762
Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant
CURBELL ELECTRONICS INC.
5401 S. COTTONWOOD CT.
GREENWOOD VILLAGE, CO 80121 US
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Contact
Kevin Walls
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Regulation Number
870.2900
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Classification Product Code
DSA
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More FDA Info for this Product Code
Date Received
06/20/2008
Decision Date
08/27/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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