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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 K112819
Device Name RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW
Original Applicant
XIAMEN DOUBLE ENGLINE MEDICAL MATERIAL CO., LTD
p.o. box 237-023
shanghai,  CN 200237
Original Contact diana hong
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received09/28/2011
Decision Date 12/16/2011
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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