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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
Applicant
WEIGAO ORTHOPAEDIC DEVICE CO., LTD
PO BOX 237-023
SHANGHAI,  CN 200237
Applicant Contact Diana Hong
Correspondent
WEIGAO ORTHOPAEDIC DEVICE CO., LTD
PO BOX 237-023
SHANGHAI,  CN 200237
Correspondent 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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