FENESTRATED INFUSION CATHETER


Device Classification Name

pump, infusion

510(k) Number K024190
Device Name FENESTRATED INFUSION CATHETER
Original Applicant
PROMEDIC, INC.
6329 west waterview ct.
mccordsville, 
IN 
46055 -9501

Original Contact paul dryden
Regulation Number 880.5725
Classification Product Code
FRN  
Date Received 12/19/2002
Decision Date 03/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No