MAKY 21.1 DIALYZER REPROCESSING SYSTEM


Device Classification Name

dialyzer reprocessing system

510(k) Number K024076
Device Name MAKY 21.1 DIALYZER REPROCESSING SYSTEM
Original Applicant
HDC MAQUINOLAS, LLC
8508 beacon bend ln.
pearland, 
TX 
77584

Original Contact lori k holder
Classification Product Code
LIF  
Date Received 12/10/2002
Decision Date 09/26/2003
Decision

substantially equivalent

(SESE)

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No