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FDA 510(k) Application Details - K123759
Device Classification Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
More FDA Info for this Device
510(K) Number
K123759
Device Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX,
2400 BERNVILLE ROAD
READING, PA 19605 US
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Contact
ELIZABETH DUNCAN
Other 510(k) Applications for this Contact
Regulation Number
880.5970
More FDA Info for this Regulation Number
Classification Product Code
LJS
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More FDA Info for this Product Code
Date Received
12/07/2012
Decision Date
01/03/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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