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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K050106
Device Name NOVOFINE AUTOCOVER 30G X 8MM
Applicant
Novo Nordisk, Inc.
100 College Rd. W.
Princeton,  NJ  08540
Applicant Contact JOHN SIGNORIN
Correspondent
Novo Nordisk, Inc.
100 College Rd. W.
Princeton,  NJ  08540
Correspondent Contact JOHN SIGNORIN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/18/2005
Decision Date 03/30/2005
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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