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FDA 510(k) Application Details - K071785
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K071785
Device Name
Needle, Hypodermic, Single Lumen
Applicant
SMITHS MEDICAL ASD, INC.
10 BOWMAN DR.
KEENE, NH 03431 US
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Contact
BRIAN FARIAS
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Regulation Number
880.5570
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Classification Product Code
FMI
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More FDA Info for this Product Code
Date Received
07/02/2007
Decision Date
08/02/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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