BEL-GEN COLD STORAGE SOLUTION


Device Classification Name

set, perfusion, kidney, disposable

510(k) Number K121618
Device Name BEL-GEN COLD STORAGE SOLUTION
Applicant
WATERS MEDICAL SYSTEMS, LLC
2112 15th st. n.w.
rochester, 
MN 
55901

Applicant Contact robert warren
Correspondent
WATERS MEDICAL SYSTEMS, LLC
2112 15th st. n.w.
rochester, 
MN 
55901

Correspodent Contact robert warren
Regulation Number 876.5880
Classification Product Code
KDL  
Subsequent Product Code
KDN  
Date Received 06/01/2012
Decision Date 06/14/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No