NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET


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
Applicant
NIPRO MEDICAL CORPORATION
3150 n.w. 107th ave.
miami, 
FL 
33172

Applicant Contact jessica oswald
Correspondent
NIPRO MEDICAL CORPORATION
3150 n.w. 107th ave.
miami, 
FL 
33172

Correspodent Contact jessica oswald
Regulation Number 876.5820
Classification Product Code
FJK  
Date Received 09/09/2011
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