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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 K120395
Device Name NERIA MULTI SUBCUTANEOUS INFUSION SET
Applicant
Unomedical Devices S.A DE C.V.
Avenida Fomento Industrial Lote 9 Manzana 3
Parque Industrial Del Norte
Reynosa,  MX C.P. 88736
Applicant Contact JOHN M LINDSKOG
Correspondent
Unomedical Devices S.A DE C.V.
Avenida Fomento Industrial Lote 9 Manzana 3
Parque Industrial Del Norte
Reynosa,  MX C.P. 88736
Correspondent Contact JOHN M LINDSKOG
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/08/2012
Decision Date 05/30/2012
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
Recalls CDRH Recalls
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