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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 K921908
Device Name NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE
Applicant
NOVO NORDISK PHARMACEUTICALS, INC.
100 OVERLOOK CTR.
PRINCETON,  NJ  08540 -7810
Applicant Contact NATHAN H BLOCK
Correspondent
NOVO NORDISK PHARMACEUTICALS, INC.
100 OVERLOOK CTR.
PRINCETON,  NJ  08540 -7810
Correspondent Contact NATHAN H BLOCK
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/23/1992
Decision Date 06/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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