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FDA 510(k) Application Details - K070613
Device Classification Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
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510(K) Number
K070613
Device Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant
ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY, NY 12804 US
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Contact
TERI JUCKETT
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Regulation Number
880.5970
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Classification Product Code
LJS
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More FDA Info for this Product Code
Date Received
03/05/2007
Decision Date
06/29/2007
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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