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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K003977
Device Name DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET
Applicant
Disetronic Medical Systems AG
5151 Program Ave.
St. Paul,  MN  55112
Applicant Contact DAVID E CHADWICK
Correspondent
Disetronic Medical Systems AG
5151 Program Ave.
St. Paul,  MN  55112
Correspondent Contact DAVID E CHADWICK
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/22/2000
Decision Date 02/15/2001
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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