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510(k) K053563

HUMAPEN MEMOIR by Eli Lilly and Company — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2006
Date Received
December 21, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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