FDA 510(k) Application Details - K953825

Device Classification Name Set, Administration, Intravascular

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510(K) Number K953825
Device Name Set, Administration, Intravascular
Applicant ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY, NY 12804 US
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Contact BRIAN KUNST
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 08/15/1995
Decision Date 02/26/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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