FDA 510(k) Application Details - K030005

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

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510(K) Number K030005
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant VANGUARD MEDICAL CONCEPTS, INC.
5307 GREAT OAK DR.
LAKELAND, FL 33815 US
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Contact MIKE SAMMON
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 01/02/2003
Decision Date 03/18/2003
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 N
Expedited Review



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