FDA 510(k) Application Details - K102430

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

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510(K) Number K102430
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant TYCO ELECTRONICS CORPORATION
10025 SW FREEMAN CT.
WILSONVILLE, OR 97070 US
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Contact DENNIS M GILKEY
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 08/26/2010
Decision Date 09/10/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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