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510(k) K100988

HUMAPEN LUXURA HD by Eli Lilly and Company — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2010
Date Received
April 9, 2010
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

Other clearances by Eli Lilly and Company

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  • K160949 — Go Dose System (December 22, 2016)
  • K142518 — HumaPen Luxura (June 5, 2015)
  • K063151 — HUMAPEN LUXURA HD (January 9, 2007)
  • K053563 — HUMAPEN MEMOIR (April 7, 2006)
  • K982842 — HUMAPEN AND HUMAPEN ERGO (September 25, 1998)

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