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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 K033892
Device Name ULTRAFLEX INFUSION SET
Applicant
DISETRONIC MEDICAL SYSTEMS AG
KIRCHBERSTRASSE 190, POSTFACH
BURGDORF,  SE CH-3401
Applicant Contact BERND HENNINGSEN
Correspondent
DISETRONIC MEDICAL SYSTEMS AG
KIRCHBERSTRASSE 190, POSTFACH
BURGDORF,  SE CH-3401
Correspondent Contact BERND HENNINGSEN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/16/2003
Decision Date 03/09/2004
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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