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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
Original Applicant
UNOMEDICAL DEVICES S.A DE C.V
avenida fomento industrial lote 9 manzana 3
parque industrial del norte
reynosa,  MX c.p. 88736
Original Contact john m lindskog
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/08/2012
Decision Date 05/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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