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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 K130468
Device Name ORBIT INFUSION SET
Applicant
Ypsomed AG
Brunnmattstrasse 6
Burgdorf,  CH CH - 3401
Applicant Contact BENJAMIN REINMANN
Correspondent
Ypsomed AG
Brunnmattstrasse 6
Burgdorf,  CH CH - 3401
Correspondent Contact BENJAMIN REINMANN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/25/2013
Decision Date 03/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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