FDA 510(k) Application Details - K041517

Device Classification Name

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510(K) Number K041517
Device Name INFUSIONCATH
Applicant ID LLC
8210 NW 27TH ST.
MIAMI, FL 33122 US
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Contact MARIO ARBESU
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Regulation Number

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Classification Product Code QEY
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Date Received 06/07/2004
Decision Date 08/05/2004
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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