RESORB-X G


Device Classification Name

plate, cranioplasty, preformed, alterable

510(k) Number K121606
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 882.5320
Classification Product Code
GWO  
Subsequent Product Code
HBW  
Date Received 06/01/2012
Decision Date 01/17/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No