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FDA 510(k) Application Details - K113241
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K113241
Device Name
Syringe, Piston
Applicant
BECTON DICKINSON
1 BECTON DR.
FRANKLIN LAKES, NJ 07417-1880 US
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Contact
KARA MCKEE
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
FMF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/02/2011
Decision Date
11/28/2011
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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