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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact JENNIFER DAMATO
Regulation Number882.5320
Classification Product Code
GWO  
Subsequent Product Code
HBW  
Date Received06/01/2012
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
Predetermined Change
Control Plan Authorized		 No
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