LUTHER SAFETY HUBER NEEDLE SET


Device Classification Name

set, administration, intravascular

510(k) Number K021565
Device Name LUTHER SAFETY HUBER NEEDLE SET
Original Applicant
LUTHER RESEARCH PARTNERS
3722 ave. sausalito
irvine, 
CA 
92606

Original Contact grey holland
Regulation Number 880.5440
Classification Product Code
FPA  
Subsequent Product Code
LJS  
Date Received 05/13/2002
Decision Date 11/14/2002
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