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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 K120375
Device Name MED-RX PATIENT DELIVERY SET
Original Applicant
BENLAN INC
2760 brighton rd
oakville,  CA l6h 5t4
Original Contact cheryl brown
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/06/2012
Decision Date 06/28/2012
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
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