FDA 510(k) Application Details - K963574

Device Classification Name Pump, Infusion

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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
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Regulation Number 880.5725

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Classification Product Code FRN
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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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