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FDA 510(k) Application Details - K081472
Device Classification Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
More FDA Info for this Device
510(K) Number
K081472
Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant
ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY, NY 12804 US
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Contact
BRIAN KUNST
Other 510(k) Applications for this Contact
Regulation Number
880.5965
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Classification Product Code
LJT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/27/2008
Decision Date
09/23/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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