RESORB X-G


Device Classification Name

plate, bone

510(k) Number K112064
Device Name RESORB X-G
Applicant
KLS-MARTIN L.P.
11201 saint johns industrial
parkway south
jacksonville, 
FL 
32246

Applicant Contact jennifer damato
Correspondent
KLS-MARTIN L.P.
11201 saint johns industrial
parkway south
jacksonville, 
FL 
32246

Correspodent Contact jennifer damato
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 07/19/2011
Decision Date 03/23/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No