BLOOD TUBING SETS (STERILE FLUID PATH)


Device Classification Name

set, tubing, blood, with and without anti-regurgitation valve

510(k) Number K080807
Device Name BLOOD TUBING SETS (STERILE FLUID PATH)
Applicant
NXSTAGE MEDICAL, INC.
439 south union st., 5th floor
lawrence, 
MA 
01843

Applicant Contact michael doyle
Correspondent
NXSTAGE MEDICAL, INC.
439 south union st., 5th floor
lawrence, 
MA 
01843

Correspodent Contact michael doyle
Regulation Number 876.5820
Classification Product Code
FJK  
Subsequent Product Code
KOC  
Date Received 03/21/2008
Decision Date 07/18/2008
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