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FDA 510(k) Application Details - K083583
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K083583
Device Name
Syringe, Piston
Applicant
NORDSON EFD
40 CATAMORE BOULEVARD
EAST PROVIDENCE, RI 02914 US
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Contact
JEFF PEMBROKE
Other 510(k) Applications for this Contact
Regulation Number
880.5860
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Classification Product Code
FMF
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More FDA Info for this Product Code
Date Received
12/04/2008
Decision Date
06/30/2009
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
Y
Expedited Review
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