OSMONICS SOLUTION DELIVERY SYSTEM


Device Classification Name

tank, holding, dialysis

510(k) Number K023011
Device Name OSMONICS SOLUTION DELIVERY SYSTEM
Original Applicant
OSMONICS MEDICAL SYSTEMS
7848 s. 202nd st.
kent, 
WA 
98032

Original Contact kristine kaliszewski
Regulation Number 876.5820
Classification Product Code
FIN  
Date Received 09/09/2002
Decision Date 06/26/2003
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