SOAKER CATHETER


Device Classification Name

pump, infusion

510(k) Number K022869
Device Name SOAKER CATHETER
Original Applicant
I-FLOW CORP.
20202 windrow dr.
lake forest, 
CA 
92630

Original Contact shane noehre
Regulation Number 880.5725
Classification Product Code
FRN  
Subsequent Product Code
MRZ  
Date Received 08/29/2002
Decision Date 09/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No