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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 K162602
Device Name NovoPen Echo
Applicant
Novo Nordisk, Inc.
P.O Box 846
Plainsboro,  NJ  08536
Applicant Contact Elizabeth D'Amato
Correspondent
Novo Nordisk, Inc.
P.O Box 846
Plainsboro,  NJ  08536
Correspondent Contact Elizabeth D'Amato
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/19/2016
Decision Date 10/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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