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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K121497
Model 1.3
Device Name VENOFER PUMP
Original Applicant
RENAL SOLUTIONS INC.
770 commonwealth drive
suite 101
warrendale,  PA  15086
Original Contact david vanella
Regulation Number876.5860
Classification Product Code
KDI  
Date Received05/21/2012
Decision Date 08/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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