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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 AVENUE.
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
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