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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
Original Applicant
11201 saint johns industrial
parkway south
jacksonville,  FL  32246
Original Contact jennifer damato
Regulation Number882.5320
Classification Product Code
Subsequent Product Code
Date Received06/01/2012
Decision Date 01/17/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No