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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 K150921
Device Name Orbit Infusion Set
Applicant
Ypsomed AG
Brunnmattstrasse 6
Burgdorf,  CH CH - 3401
Applicant Contact STEPHAN AFFOLTER
Correspondent
P/L Biomedical
10882 Stonington Ave.
Fort Myers,  FL  33913
Correspondent Contact LEE LEICHTER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/06/2015
Decision Date 04/12/2016
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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