SONICWELD RX (RESORB-X)


Device Classification Name

plate, bone

510(k) Number K080862
Device Name SONICWELD RX (RESORB-X)
Applicant
KLS-MARTIN L.P.
11239 st. johns ind pkwy south
jacksonville, 
FL 
32246

Applicant Contact tom faucett
Correspondent
KLS-MARTIN L.P.
11239 st. johns ind pkwy south
jacksonville, 
FL 
32246

Correspodent Contact tom faucett
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 03/27/2008
Decision Date 07/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No