NXSTAGE PUREFLOW SL


Device Classification Name

subsystem, proportioning

510(k) Number K080919
Device Name NXSTAGE PUREFLOW SL
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
FKR  
Date Received 04/01/2008
Decision Date 10/15/2008
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

Yes

Recalls CDRH Recalls