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FDA 510(k) Application Details - K100635
Device Classification Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
More FDA Info for this Device
510(K) Number
K100635
Device Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant
ARROW INTL., INC.
2400 BERNVILLE RD.
READING, PA 19605 US
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Contact
TRACY MADDOCK
Other 510(k) Applications for this Contact
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
03/05/2010
Decision Date
08/27/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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