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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, Orthodontic
510(k) Number K110392
Device Name PSM LOMAS / BENEFIT SCREWS
Applicant
PSM MEDICAL SOLUTIONS
SCHWARZWALDSTRASSE 5
TUTTLINGEN BW,  DE 78532
Applicant Contact ANDREA PECSI
Correspondent
PSM MEDICAL SOLUTIONS
SCHWARZWALDSTRASSE 5
TUTTLINGEN BW,  DE 78532
Correspondent Contact ANDREA PECSI
Regulation Number872.3640
Classification Product Code
OAT  
Date Received02/11/2011
Decision Date 12/14/2011
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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