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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K073556
Device Name MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS
Applicant
MEDXPERT GMBH
GRIESWEG 47
MUHLHEIM, BADEN-WURTTEMBERG,  DE 78570
Applicant Contact FRANZ MENEAN
Correspondent
MEDXPERT GMBH
GRIESWEG 47
MUHLHEIM, BADEN-WURTTEMBERG,  DE 78570
Correspondent Contact FRANZ MENEAN
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/19/2007
Decision Date 06/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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