HF JUNIOR HEMOFILTER

Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K071298
Device Name HF JUNIOR HEMOFILTER
Applicant
MINNTECH CORP.
14605 28th ave. north
minneapolis, 
MN 
55447

Applicant Contact lynn lueders
Correspondent
MINNTECH CORP.
14605 28th ave. north
minneapolis, 
MN 
55447

Correspodent Contact lynn lueders
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 05/09/2007
Decision Date 08/08/2007
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