FDA 510(k) Application Details - K040446

Device Classification Name Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

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510(K) Number K040446
Device Name Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY, NY 12804 US
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Contact TERI JUCKETT
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Regulation Number 880.5970

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Classification Product Code LJS
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Date Received 02/20/2004
Decision Date 03/05/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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