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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K042345
Device Name LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)
Applicant
Mondeal Medical Systems GmbH
Amstel 320-1
Amsterdam,  NL 1017AP
Applicant Contact ANGELIKA SCHERP
Correspondent
Mondeal Medical Systems GmbH
Amstel 320-1
Amsterdam,  NL 1017AP
Correspondent Contact ANGELIKA SCHERP
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/30/2004
Decision Date 01/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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