LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER


Device Classification Name

plate, bone

510(k) Number K030425
Device Name LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER
Applicant
WALTER LORENZ SURGICAL, INC.
1520 tradeport dr.
jacksonville, 
FL 
32218

Applicant Contact kim reed
Correspondent
WALTER LORENZ SURGICAL, INC.
1520 tradeport dr.
jacksonville, 
FL 
32218

Correspodent Contact kim reed
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 02/10/2003
Decision Date 05/14/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No