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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K101902
Device Name J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030
Applicant
Jeil Medical Corporation
1733 Canton Ln.
Marietta,  GA  30062
Applicant Contact CATHY CAMBRIA
Correspondent
Jeil Medical Corporation
1733 Canton Ln.
Marietta,  GA  30062
Correspondent Contact CATHY CAMBRIA
Regulation Number872.4880
Classification Product Code
DZL  
Date Received07/08/2010
Decision Date 02/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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