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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 K013782
Device Name DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE
Applicant
DISETRONIC MEDICAL SYSTEMS
5151 PROGRAM AVE.
ST. PAUL,  MN  55112 -1014
Applicant Contact DAVID E CHADWICK
Correspondent
DISETRONIC MEDICAL SYSTEMS
5151 PROGRAM AVE.
ST. PAUL,  MN  55112 -1014
Correspondent Contact DAVID E CHADWICK
Regulation Number880.5570
Classification Product Code
FMI  
Date Received11/14/2001
Decision Date 11/20/2001
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
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