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FDA 510(k) Application Details - K061733
Device Classification Name
Catheter, Intravascular, Diagnostic
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510(K) Number
K061733
Device Name
Catheter, Intravascular, Diagnostic
Applicant
ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY, NY 12804 US
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Contact
TERI JUCKETT
Other 510(k) Applications for this Contact
Regulation Number
870.1200
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Classification Product Code
DQO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/20/2006
Decision Date
08/24/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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