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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
Applicant Contact DAVID E CHADWICK
Correspondent
Disetronic Medical Systems
5151 Program Ave.
St. Paul,  MN  55112
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
Predetermined Change
Control Plan Authorized		 No
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