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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K151686
Device Name HumanPen Ergo II
Applicant
ELI LILLY AND COMPANY, INC.
LILLY CORPORATE CENTER
INDIANAPOLIS,  IN  46285
Applicant Contact CHRISTINE A. PHILLIPS
Correspondent
ELI LILLY AND COMPANY, INC.
LILLY CORPORATE CENTER
INDIANAPOLIS,  IN  46285
Correspondent Contact CHRISTINE A. PHILLIPS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/23/2015
Decision Date 12/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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