SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM


Device Classification Name

glucose oxidase, glucose

510(k) Number K023194
Device Name SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
Original Applicant
LIFESCAN, INC.
1000 gibraltar dr.
milpitas, 
CA 
95035 -6312

Original Contact jojn e hughes
Regulation Number 862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received 09/25/2002
Decision Date 10/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls