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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 K100988
Device Name HUMAPEN LUXURA HD
Applicant
Eli Lilly and Company
Lilly Corporate Center
Indianapolis,  IN  46285
Applicant Contact STEVEN T JOHNSON PE, MBA
Correspondent
Eli Lilly and Company
Lilly Corporate Center
Indianapolis,  IN  46285
Correspondent Contact STEVEN T JOHNSON PE, MBA
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/09/2010
Decision Date 08/17/2010
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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