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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calculator, drug dose
510(k) Number K160949
Device Name Go Dose System
Applicant
ELI LILLY AND COMPANY
LILLY CORPORATE CENTER
indianapolis,  IN  46285
Applicant Contact sumitra m ghate
Correspondent
ELI LILLY AND COMPANY
LILLY CORPORATE CENTER
indianapolis,  IN  46285
Correspondent Contact sumitra m ghate
Regulation Number868.1890
Classification Product Code
NDC  
Subsequent Product Code
LNX  
Date Received04/05/2016
Decision Date 12/22/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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