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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 K111761
Device Name NEO TITANIUM MESH, CTI-MEM
Applicant
NEOBIOTECH CO., LTD.
1733 CANTON LANE
MARIETTA,  GA  30006
Applicant Contact RON ARKIN
Correspondent
NEOBIOTECH CO., LTD.
1733 CANTON LANE
MARIETTA,  GA  30006
Correspondent Contact RON ARKIN
Regulation Number872.4760
Classification Product Code
JEY  
Date Received06/23/2011
Decision Date 01/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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