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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
Applicant
BENLAN INC
2760 brighton rd
oakville,  CA l6h 5t4
Applicant Contact cheryl brown
Correspondent
BENLAN INC
2760 brighton rd
oakville,  CA l6h 5t4
Correspondent 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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