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FDA 510(k) Application Details - K963574
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K963574
Device Name
Pump, Infusion
Applicant
ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY, NY 12804 US
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Contact
JEFFREY R MANNION
Other 510(k) Applications for this Contact
Regulation Number
880.5725
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Classification Product Code
FRN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/06/1996
Decision Date
07/18/1997
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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