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FDA 510(k) Application Details - K151686
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K151686
Device Name
Syringe, Piston
Applicant
ELI LILLY AND COMPANY, INC.
LILLY CORPORATE CENTER
INDIANAPOLIS, IN 46285 US
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Contact
CHRISTINE A. PHILLIPS
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
06/23/2015
Decision Date
12/30/2015
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
N
Expedited Review
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