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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name rod, fixation, intramedullary and accessories
510(k) Number K121312
Device Name INTRAMEDULLARY NAIL SYSTEM
Original Applicant
WEIGAO ORTHOPAEDIC DEVICE CO., LTD
po box 237-023
shanghai,  CN 200237
Original Contact diana hong
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/01/2012
Decision Date 10/24/2012
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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