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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 K053563
Device Name HUMAPEN MEMOIR
Applicant
ELI LILLY AND COMPANY
LILLY CORPORATE CENTER
INDIANAPOLIS,  IN  46285
Applicant Contact LEEANN CHAMBERS
Correspondent
ELI LILLY AND COMPANY
LILLY CORPORATE CENTER
INDIANAPOLIS,  IN  46285
Correspondent Contact LEEANN CHAMBERS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/21/2005
Decision Date 04/07/2006
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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