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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 K103778
Device Name LEFORTE NEURO SYSTEM BONE PLATE
Applicant
Jeil Medical Corporation
5966 Exeter Cir.
Norcross,  GA  30071
Applicant Contact PAUL SUMNER
Correspondent
Jeil Medical Corporation
5966 Exeter Cir.
Norcross,  GA  30071
Correspondent Contact PAUL SUMNER
Regulation Number872.4760
Classification Product Code
JEY  
Date Received12/27/2010
Decision Date 01/26/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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