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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 K053470
Device Name NOVOFINE 32G TIP
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 Received12/14/2005
Decision Date 12/21/2005
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 No
Predetermined Change
Control Plan Authorized		 No
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