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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, bone
510(k) Number K112064
Device Name RESORB X-G
Original Applicant
11201 saint johns industrial
parkway south
jacksonville,  FL  32246
Original Contact jennifer damato
Regulation Number872.4760
Classification Product Code
Date Received07/19/2011
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