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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 K132142
Device Name NERIA SOFT 90 INFUSION SET
Applicant
Unomedical A/S
Unit B9, Taylors Ct., Parkgate
Rotherham, Sout Yorkshire,  GB S62 6NU
Applicant Contact DEIRDRE BARROW
Correspondent
Unomedical A/S
Unit B9, Taylors Ct., Parkgate
Rotherham, Sout Yorkshire,  GB S62 6NU
Correspondent Contact DEIRDRE BARROW
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/11/2013
Decision Date 10/08/2013
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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