FDA 510(k) Application Details - K081762

Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)

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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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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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