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FDA 510(k) Application Details - K071998
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K071998
Device Name
Needle, Hypodermic, Single Lumen
Applicant
ARROW INTL., INC.
P.O. BOX 12888
READING, PA 19612-2888 US
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Contact
KIRSTEN STOWELL
Other 510(k) Applications for this Contact
Regulation Number
880.5570
More FDA Info for this Regulation Number
Classification Product Code
FMI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/23/2007
Decision Date
09/26/2007
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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