FDA 510(k) Application Details - K082959

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

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510(K) Number K082959
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant UNIMED MEDICAL SUPPLIES INC.
NO.37, YANSHAN ROAD, SHEKOU
SHENZHEN, GUANGDONG 518067 CN
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Contact LIMING XUE
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 10/03/2008
Decision Date 10/10/2008
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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