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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
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