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FDA 510(k) Application Details - K953746
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K953746
Device Name
Set, Administration, Intravascular
Applicant
ARROW INTL., INC.
3000 BERNVILLE RD.
READING, PA 19605 US
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Contact
THOMAS D NICKEL
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/10/1995
Decision Date
01/26/1996
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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