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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 K071797
Device Name MONDEAL HAND CONTOUR SYSTEM
Applicant
Mondeal Medical Systems GmbH
13566 Freeport Rd.
San Diego,  CA  92133
Applicant Contact JAY EVANS
Correspondent
Mondeal Medical Systems GmbH
13566 Freeport Rd.
San Diego,  CA  92133
Correspondent Contact JAY EVANS
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/02/2007
Decision Date 09/17/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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