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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, tubing, blood, with and without anti-regurgitation valve
510(k) Number K112628
Device Name NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
Original Applicant
NIPRO MEDICAL CORPORATION
3150 n.w. 107th ave.
miami,  FL  33172
Original Contact jessica oswald
Regulation Number876.5820
Classification Product Code
FJK  
Date Received09/09/2011
Decision Date 09/28/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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